Modes of Failure of Guide Catheter Extensions: Insights From the MAUDE Database

Objectives. Guide catheter extensions (GCEs) are commonly used to facilitate percutaneous coronary interventions (PCIs). We investigated the incidence and modes of failure of GCEs.

Methods. Data from the Manufacturer and User Facility Device Experience (MAUDE) database between 2012 and 2022 were used to investigate the most common modes of failure and related adverse events with the use of GCEs. We performed analysis of 4 commonly used catheters: GuideLiner (Teleflex), Guidezilla (Boston Scientific), TrapLiner (Teleflex), and Telescope (Medtronic). The first event reported for GuideLiner was in 2012, Guidezilla in 2018, TrapLiner in 2017, and Telescope in 2019.

Results. During the study period, a total of 651 events were reported to the database. A total of 429 true GCE device failures were identified: 59 (14%) for GuideLiner, 297 (69%) for Guidezilla, 47 (11%) TrapLiner, and 26 (6%) for Telescope. Catheter detachment or fracture was the most frequently reported device failure for all 4 GCEs; these failures included shaft fractures, tip deformations, and collar detachments. We identified 222 reported events as unspecified adverse events; these events included device-to-device incompatibility, difficulty to advance, and device fractures outside the patient body. Only 58 (8.9%) events resulted in patient complication. Of these, coronary artery dissection was the most frequently reported complication.

Conclusions. Device detachment/fracture is the most common mode of device failure in all 4 GCEs, and coronary dissection is the most common patient complication.

Guide catheter extensions (GCEs) can facilitate percutaneous coronary intervention (PCI) through better vessel engagement and increased support for equipment delivery. GCEs can also facilitate chronic total occlusion (CTO) PCI (eg, GCE-assisted reverse-controlled antegrade and retrograde subintimal tracking).^1-5 There are 4 commonly used GCEs in the United States: GuideLiner (Teleflex,), Guidezilla (Boston Scientific), TrapLiner (Teleflex; combination of GCE and a trapping balloon), and Telescope (Medtronic).

Although GCEs are often successful,⁶ they carry risk of complications such as device failure, vascular dissection, and stent dislodgment.^6-11 There is limited data on real-life modes of failure and complications of GCEs. We investigated the GCE failure reports submitted to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database registry during the last decade.¹² A prior similar report from the MAUDE database was limited to GuideLiner and Guidezilla GCEs and reported cases for GuideLiner from 2010 to 2018 and for Guidezilla from 2016 to 2018.⁷
 

MAUDE database. The FDA MAUDE database is an online database of adverse events related to approved medical devices. Reporting to the MAUDE database is either mandatory (for manufacturers and device user facilities) or voluntary (for healthcare professionals, patients, and consumers). It is a beneficial tool for post-marketing surveillance of medical devices. Each medical device report contains information on the device, event date, whether the device was returned to the manufacturer for evaluation, free text description of the event by the user, and the manufacturer’s narrative.^7,13,14

Data collection. We conducted a retrospective analysis of all events reported to MAUDE involving GuideLiner, Guidezilla, TrapLiner, and Telescope GCEs between 2012 and 2022.

During the study period, there were 85 cases reported on the GuideLiner catheter from 2012 to 2022, 474 on the Guidezilla from 2018 to 2022, 59 on the TrapLiner from 2017 to 2022, and 33 on the Telescope from 2019 to 2022. The Guidezilla had the highest number of reported cases from 2019 to 2020, with a sharp decline since then (Figure 1), while reported cases on the other 3 GCEs remained steady during the study period.

Modes of failure and clinical outcomes. Different modes of device failure for each device are presented in Table 1 and Figure 2, and the patient complications due to device failure are presented in Table 2 and Figure 3A-D. The most common mode of device failure noted in all 4 devices is the detachment/fracture of the device in the vessel during use, while coronary dissection was noted to be the most common patient complication related to all 4 devices. Other common modes of device failure reported were device entrapment and material deformation. Material embolization was one of the commonly observed complications with the use of Guidezilla and Telescope. There was a significant number of cases reported for device failures with no clinical complications, as stated in Table 2. There were also additional modes of failure reported in the database, which were adjudicated to not be true procedure-related device failures, eg, device malformations outside the patient body, device-to-device incompatibility, and difficulty in advancing the device (Table 1B).

It was observed that the cases reported to the MAUDE were not necessarily associated with clinical complications. Several of the cases were reported solely for device malformation without clinical complications.¹² There were also cases that reported complications due to device malformation; for example, in one of the cases, the tip of the Telescope was observed to have detached and embolized to the mid-left anterior descending artery.¹² Additionally, we observed cases in which complications occurred during device manipulation.¹² For instance, there were cases in which the GuideLiner was introduced into the patient body and the stent was stuck at the collar transition section of the GuideLiner, which resulted in an RCA acute closure and dissection.¹²

Upon evaluation of the event description available in the MAUDE database, only a limited number of cases explained the mechanism of device failure and management in detail. The device detachment/fractures included shaft fractures, collar/tip detachments, tip deformations, and problems with the half-pipe. There were cases reported for shaft kinking and peeling of the material. Device-to-device incompatibility between guide catheter extensions and stent delivery systems was also observed.  Most of the coronary dissections were treated with stenting, and only 2 cases of dissection related to GuideLiner required coronary artery bypass graft surgery; 1 case of Guidezilla-related dissection was treated surgically. There was 1 case of thrombus formation from the GuideLiner, which was treated with aspiration and anticoagulation. Snaring technique was mostly used for retrieval of embolized parts. Surgery was required for 1 reported case of foreign body retrieval involving a Guidezilla catheter. The available event description in the database showed that all the defective devices were immediately removed from the patient's body by the users and replaced by new devices of the same or different brand to complete the procedure.

Our study aimed to analyze the mechanism of device failure, complications, and outcomes associated with the use of 4 GCE systems. We utilized the real-life data from the MAUDE database over the past decade. Our main findings were that (a) the most common mode of failure was detachment/fracture of the device, and (b) the most commonly reported patient complication was coronary dissection, followed by device material embolization. The incidence of device-related failures or complications cannot be calculated from the MAUDE database since the denominator (overall device utilization) is not known, and therefore direct head-to-head comparison cannot be made between catheters.

The GuideLiner GCE was approved by the FDA in 2009. Since then, different generations of GuideLiner have been introduced with improved designs to facilitate smooth device entry and delivery. These catheters have an internal diameter of approximately one French size smaller than the guide catheters. The GuideLiner V3 and the GuideLiner V3 Coast are the latest models available in the market.^6,7,15-17

The Guidezilla GCE was approved by the FDA in 2013. The current second-generation Guidezilla II GCE system has a new platinum-iridium helical collar, which improves visibility. To reduce device interaction, the hypotube length was reduced from 19 mm to 6 mm in the second-generation design.^1,6,7

The TrapLiner catheter is a 2-in-1 designed rapid exchange catheter that combines the ability to provide backup support with the ability to trap a 0.014-inch guidewire with an integrated trapping balloon. The TrapLiner was approved by the FDA in 2017. The TrapLiner catheter can be used as an alternative to the trapping technique that requires the use of an angioplasty or dedicated trapping balloons to exchange an existing over-the-wire catheter while maintaining guidewire position.^1,18

The Telescope GCE was approved by the FDA in 2019. It resembles the 2 aforementioned predecessors with few differences; it has a color-coded hub matching the conventional industry French sizes, a solid round proximal push wire, and a 2-mm soft flexible polymer tip.¹ Overall, the design of these catheters is similar, with minor differences in construction as illustrated in Figure 4 and Table 3.

The use of GCEs has grown over the past decade as the complexity of coronary interventions has increased. GCEs facilitate equipment delivery and increase the success rate of complex PCI.⁶ The most common complication associated with the use of GCEs is coronary artery dissection, the risk of which can be mitigated with distal delivery of these catheters using balloon-assisted tracking techniques.¹⁹ Nonetheless, delivery of these catheters through complex calcified vessels may compromise the structural integrity of the device.

The most reported GCE-related failures in the literature include stent loss and deformation, and displacement of the GuideLiner catheter distal marker into the coronary artery.⁹ Stent deformation or loss is much less common with lower profile coronary stents and with new iterations of GCEs due to improvements in the collar design. The most reported device-related failure to the MAUDE, however, is device detachment or fracture resulting in coronary dissection or material embolization. Although Guidezilla has the highest number of reported adverse events to MAUDE, this may be due to a higher utilization of this catheter relative to others. Given that the denominator is unknown, no meaningful comparison can be drawn between different devices.

GCEs could be subject to high degrees of stress during manipulation in tortuous and calcified vessels that may compromise the device integrity and industrial bonding, leading to the failures noted. Good practice strategies for the use of GCEs include the following:

1. Adequate vessel preparation: Calcium modification strategies would allow for maximal stent expansion and easier GCE delivery or obviating its use.
2. Avoid excessive forward push or pull: Balloon-assisted tracking facilitates delivery and reduces the risk of coronary dissection and possibly device deformation.
3.  Prior to first use or re-insertion of the GCE, examine for any prior deformation and do not use if any is present.
4. Avoid contrast injection through the GCEs if possible; if contrast injection is considered, careful attention must be paid to guide pressure prior to any injection, avoiding use of automated injectors. Moreover, the GCE pushrod should be held during injections—even when the GCE is withdrawn inside the guide catheter—to prevent the hydrophilic-coated catheter from “hydroplaning” and jumping forward, potentially causing coronary dissection or perforation.
5. Ensure optimal therapeutic anticoagulation during the procedure, and aspirate and de-air the guide catheter after removal of the GCE. Waterbury et al noted a decline in device-associated complications over time, which they attributed to the operator learning curve, patient selection, and improvement in GCE design.¹¹

Limitations. Our study has limitations. First, it is a retrospective analysis of the MAUDE database that can be limited by selection bias and reporting bias from healthcare professionals. Second, the MAUDE database may include limited details on the performed procedures. Finally, our sample’s denominator is unknown, hence the incidence rate of each GCE’s mode of failure cannot be calculated. Lastly, it is difficult to establish a causal relationship between device failure and clinical adverse events.

Device detachment/fracture is the most common mode of device failure in all 4 available GCEs, and coronary dissection is the most reported patient complication. With new advancements in guide catheter extension design and improved operator experience, GCE-related adverse events can be reduced.

From ¹Florida Atlantic University, Boca Raton, Florida, USA; the ²University of Texas Southwestern Medical Center, Dallas, Texas, USA; ³Minneapolis Heart Institute, Minneapolis, Minnesota, USA; ⁴Memorial Healthcare System, Hollywood, Florida, USA.

Disclosures: Dr Brilakis receives consulting/speaker honoraria from Abbott Vascular, the American Heart Association (Associate Editor, Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, and the Cardiovascular Innovations Foundation, for which he serves on the Board of Directors, Advisory Board, and Speaker Bureau. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence: Sana Shaukat, MD, Boca Regional Hospital, FAU Internal Medicine Residency, Boca Raton, FL, USA. Email: sana_shaukat09@hotmail.com