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	05/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during an ischemic stroke thrombectomy procedure, a 7f zebra catheter was used to track over a 6f penumbra sim2 select catheter into the internal carotid artery.Following the withdrawal of the sim2, a penumbra red 72 aspiration catheter was introduced for advancement through the zebra.Upon advancement into the brachiocephalic artery, resistance was encountered, and the zebra catheter was suspected to have kinked, preventing further advancement of the red 72.A subsequent attempt using a red 62 catheter was also unsuccessful.The procedure was ultimately completed using a bmx 81 and red 62 catheter.No patient harm or adverse events were reported.The device was returned and received by the manufacturer with no parts visually missing.Failure analysis of the reported was performed.Visual inspection of the returned zebra catheter revealed a fracture-rather than a kink-with the device separating into two segments during removal of the red 62 catheter.The proximal and distal segments of the returned lct catheter was kink tested and met the defined performance specifications.Based on the complaint details, procedural context, and visual findings, the most probable cause of the fracture is excessive mechanical force or torquing during advancement against resistance.This aligns with the zebra catheter's instructions for use (ifu), which caution that manipulation or torquing against resistance may result in damage to the vessel or device.Although no kinks were observed in the returned product, the procedural account supports a failure mode involving device deformation under stress.

• 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
• MDR Report Key: 22307452
• Report Number: 3015614-2025-00006
• Device Sequence Number: 8655300
• Product Code: DQY
• UDI-Device Identifier: 00857545008233
• UDI-Public: 00857545008233
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/18/2025

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 Expiration Date: 10/18/2025
• Device Model Number: FG 01764-01
• Device Catalogue Number: AC7087-095-20-B
• Device Lot Number: FG250421C-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2025
• 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 Age: 79 YR
• Patient Sex: Unknown