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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On january 16, 2026, q'apel medical became aware of an event involving a zebra catheter.During a radial mma embolization procedure, the user observed a kink in the catheter shaft.The procedure was completed using an alternate catheter with no reported patient injury.Evaluation of the returned device confirmed a localized catheter wall breach/fracture located approximately 9 cm distal to the strain relief, as evidenced by fluid leakage during flushing.Visual inspection confirmed a localized kink in the shaft at this same location, consistent with the reported complaint.Additional kinks were also observed approximately 5 cm proximal to the distal tip.Microscopic and visual inspection of the damaged region identified no abnormal coil spacing or pitch variation, and the distal tip showed no abnormalities.The observed damage pattern was consistent with localized mechanical deformation/stretching.No evidence of a design anomaly or manufacturing defect was observed within the scope of the returned product evaluation.

• 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: 24357076
• Report Number: 3015614-2026-00005
• Device Sequence Number: 11993666
• Product Code: DQY
• UDI-Device Identifier: 00857545008233
• UDI-Public: 00857545008233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/16/2026

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: FG250925D-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown