MAUDE Adverse Event Report: Q'APEL MEDICAL INC. ZEBRA; Catheter, percutaneous

Model Number	FG 01764-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, during a left carotid artery stenting (cas) procedure performed via right radial access, a zebra catheter was positioned in the proximal common carotid artery.Due to near-complete occlusion of the left internal carotid artery, multiple attempts were made to advance ancillary devices.During one attempt, contrast leakage was visualized fluoroscopically from the catheter at the curve of the brachiocephalic artery.The catheter remained in position to provide support and was withdrawn following completion of the procedure.No fragments were retained, and no patient injury or adverse clinical outcome was reported.Evaluation of the returned device confirmed a catheter shaft breach approximately 19 cm from the distal tip (77 cm from the hub), as evidenced by fluid leakage during flushing.The device was returned in one piece.Microscopic and visual inspection of the fracture region demonstrated uniform reinforcement cut spacing with no abnormal pitch variation or reinforcement strut fracture.The damage pattern was characterized by localized mechanical strain between reinforcement cuts, resulting in shearing of the outer polymer jacket and a slight opening of the internal ptfe liner.No evidence of material defect, improper lamination, abnormal feed gap, exposed reinforcement, structural anomaly, or other manufacturing nonconformance was identified.

• Brand Name: ZEBRA
• Common Device Name: Catheter, percutaneous
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont CA 94538
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 4245 technology drive; fremont CA 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont, CA 94538
• MDR Report Key: 24480485
• Report Number: 3015614-2026-00010
• Device Sequence Number: 18711520
• Product Code: DQY
• UDI-Device Identifier: 00857545008233
• UDI-Public: 00857545008233
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K240746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG 01764-01
• Device Catalogue Number: AC7087-095-20-B
• Device Lot Number: FG250918D-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown