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

Catalog Number	AC7087-095-20-B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a radial access carotid stent procedure, the user observed a kink and a small hole on a zebra catheter after completion of the procedure and following removal of the device from the patient.The procedure was completed successfully and without reported patient injury, and the device was set aside for return evaluation.The user reported that no resistance or torquing was encountered during use.Evaluation of the returned device confirmed a catheter breach/fracture approximately 12 cm from the hub, as evidenced by fluid leakage during flushing.Three kink locations were identified along the catheter shaft; however, only one location exhibited a confirmed breach/fracture, with the remaining kink regions showing no visible breach characteristics.Microscopic and visual inspection of the fracture region showed uniform reinforcement cut spacing with no indication of reinforcement fracture.The observed damage pattern was consistent with localized overstretching between reinforcement cuts resulting in shearing of the outer jacket and a slight opening of the internal ptfe liner.No evidence of design or manufacturing nonconformance (e.G., improper lamination, abnormal feed gap, exposed reinforcement, or structural anomaly) 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: 24310855
• Report Number: 3015614-2026-00002
• Device Sequence Number: 4838087
• Product Code: DQY
• UDI-Device Identifier: 00857545008233
• UDI-Public: 00857545008233
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/10/2026

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 Expiration Date: 01/13/2026
• Device Catalogue Number: AC7087-095-20-B
• Device Lot Number: FG250717D-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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: Male