Device-specific failure patterns of guide catheter extensions in percutaneous coronary intervention: A contemporary MAUDE database analysis (2022-2025).

PURPOSE: To characterize the spectrum and distribution of adverse events and device malfunctions associated with guide catheter extensions (GCEs) reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database from 2022 to 2025.

METHODS: We performed a retrospective analysis of all MAUDE reports submitted between January 2022 and May 2025 involving four commercially available GCEs: GuideLiner (Teleflex), Guidezilla (Boston Scientific), TrapLiner (Teleflex), and Telescope (Medtronic). Each MAUDE submission was defined as a "report," while individual device malfunctions or patient complications documented within a report were defined as "events"; a single report could contain multiple events. Prior to data extraction, categories for device-related events (advancement difficulty, structural breakage, material separation, dislodgment, deformation, and device-device incompatibility) and patient-related events (dissection, perforation, device embedding, embolism, hematoma, and myocardial infarction) were pre-specified on the basis of prior literature and FDA device problem codes. Patient-related events were further stratified as major or minor complications. Two investigators independently reviewed MAUDE narratives and classified events; discrepancies were resolved by consensus. All percentages represent the proportion of events within each device's total event count. Because the MAUDE database does not capture total device usage, true complication rates cannot be calculated, and comparative device safety cannot be assessed.

RESULTS: A total of 363 reports containing 867 events were identified. Of these, 450 (51.9%) were device-related events and 417 (48.1%) were patient-related events. Among device-related events, Guidezilla accounted for the largest proportion (n = 295; 65.5%), followed by Telescope (n = 120; 26.6%), TrapLiner (n = 23; 5.1%), and GuideLiner (n = 12; 2.6%). Predominant failure modes varied by device: advancement difficulty (22.0%) and structural breakage (17.3%) for Guidezilla; material separation (56.5%) and material splits, cuts, or tears (17.4%) for TrapLiner; device dislodgment (30.0%) and material deformation (17.5%) for Telescope; and material separation (25.0%) and device-device incompatibility (25.0%) for GuideLiner. Among patient-related events, clinically significant major complications included vascular dissection (7.7% of GuideLiner and 3.9% of Guidezilla patient-related events), device embedding in tissue (9.3% of Telescope patient-related events), and rare occurrences of foreign body embolism, perforation, and myocardial infarction, primarily associated with TrapLiner and Telescope. A substantial proportion of reports did not describe associated clinical complications, suggesting that many device malfunctions may have been managed without adverse patient outcomes.

CONCLUSIONS: Guidezilla accounted for the largest number of GCE-related adverse event reports, a finding that may reflect its broader utilization in complex PCI rather than a higher complication rate. Each device demonstrated characteristic failure patterns. Although most reported events appeared non-serious, clinically significant complications-including vascular dissection, device embedding, and foreign body embolism-did occur. These findings describe reporting patterns and cannot establish true complication rates or comparative device safety. Operator familiarity with device-specific failure modes and adherence to evidence-based techniques remain essential for safe GCE use.