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

Model Number	FG 01195-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2026, q'apel medical became aware of a reported zebra 6f 95 cm bernstein catheter fracture that occurred during a pipeline embolization procedure.The device was introduced via a merit 22 cm 7f sheath and advanced to the high petrous carotid through tortuous anatomy, including a 360-degree cervical carotid loop.The catheter was inspected prior to use and no defects were observed.The procedure was completed successfully with no reported patient injury.During withdrawal of the zebra catheter through the stationary sheath, which was not retracted, resistance was encountered in the cervical carotid region.The physician reported that the catheter was not rotated, no vasospasm occurred, and no excessive forward pressure was applied.The physician indicated the malfunction likely occurred during withdrawal.Following removal, a kink was observed and fluid leakage was noted at the kink site.No multiple repositioning attempts were required, and no tip modification was performed.The device was removed from the patient and no additional intervention was required.The device was returned to the manufacturer for evaluation on (b)(6), 2026.Returned product analysis confirmed a catheter fracture with lumen breach approximately 7 cm from the distal tip, correlating with the reported distal kink location and consistent with the region subjected to resistance during withdrawal through tortuous cervical carotid anatomy.Flushing confirmed fluid leakage at the fracture location.Microscopic and visual inspection of the fracture region demonstrated uniform reinforcement cut spacing with no abnormal pitch variation, no reinforcement strut fracture, and no evidence of material or manufacturing nonconformance.The distal tip, including the first centimeter from the tip, showed no abnormalities.Overall device length was consistent with product specification.Additional shaft damage and minor ovalization were observed at locations not reported during the clinical event and away from the primary fracture site.These observations are inconsistent with the reported in-procedure malfunction and are most consistent with post-procedure handling and return packaging.

• 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: 24676979
• Report Number: 3015614-2026-00012
• Device Sequence Number: 10331631
• Product Code: DQY
• UDI-Device Identifier: 00857545008189
• UDI-Public: 00857545008189
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/24/2026

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 01195-01
• Device Catalogue Number: AC6074-095-20
• Device Lot Number: FG250825C-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown