Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database

Yuefeng Chen; Arhum A Shah; Evan Shlofmitz; Nauman Khalid; Anees Musallam; Jaffar M Khan; Micaela Iantorno; Deepakraj Gajanana; Toby Rogers; Hayder Hashim; Nelson L Bernardo; Ron Waksman

doi:10.1016/j.carrev.2019.02.016

Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database

Cardiovasc Revasc Med. 2019 May;20(5):409-412. doi: 10.1016/j.carrev.2019.02.016. Epub 2019 Feb 18.

Affiliations

¹ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
² Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.
³ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America. Electronic address: ron.waksman@medstar.net.

PMID: 31079818
DOI: 10.1016/j.carrev.2019.02.016

Abstract

Background/purpose: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters.

Methods/materials: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events.

Results: Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon.

Conclusions: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters.

Summary: To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.

Keywords: Complications; Guide extension catheter; Percutaneous coronary intervention.

MeSH terms

Cardiac Catheters / adverse effects*
Coronary Artery Disease / diagnostic imaging
Coronary Artery Disease / mortality
Coronary Artery Disease / therapy*
Databases, Factual
Equipment Design
Equipment Failure
Humans
Percutaneous Coronary Intervention / adverse effects*
Percutaneous Coronary Intervention / instrumentation*
Percutaneous Coronary Intervention / mortality
Product Surveillance, Postmarketing*
Risk Assessment
Risk Factors
Treatment Outcome
United States
United States Food and Drug Administration