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

Model Number	FG 01504-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, during a neurovascular procedure performed via femoral access, a zebra 7f 95 cm catheter was utilized with a cordis 5f sim 125 cm diagnostic catheter while navigating tortuous iliac anatomy and tracking across the aortic arch.During use, resistance was reportedly encountered and saline leakage was observed from a kinked region of the zebra catheter approximately 1 inch distal to the strain relief segment.The sim catheter was subsequently identified to be fractured within the zebra catheter.The proximal portion of the sim catheter was removed, after which the zebra catheter was partially withdrawn and cut to expose the retained sim catheter segment.The zebra and retained sim catheter segment were then clamped together and removed simultaneously from the patient.The separated sim catheter segment remained accessible outside the patient vasculature; removal was completed without invasive retrieval or surgical intervention, no retained fragments remained in the patient, and no patient injury or medical intervention to preclude permanent impairment was reported.The physician subsequently converted to another catheter, and the procedure was completed successfully.Returned product evaluation confirmed significant shaft deformation and a localized lumen breach/kink near the proximal zebra shaft, consistent with the reported leakage location.Additional shaft flattening and compression damage appeared consistent with physician retrieval maneuvers involving forceps manipulation and intentional cutting of the catheter to facilitate removal of the retained sim catheter segment.Evaluation of the returned devices identified no evidence of manufacturing nonconformance or material anomaly.

• 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: 25319738
• Report Number: 3015614-2026-00019
• Device Sequence Number: 5181157
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/28/2026

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 01504-01
• Device Catalogue Number: AC7087-095-20-S
• Device Lot Number: FG260105D-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 5F SIM 125 CM DIAGNOSTIC CATHETER.
• Patient Sex: Unknown