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

Model Number	FG 01194-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a neurovascular procedure, a zebra 6 fr catheter (fg 01194-01, lot fg250917c-02) with a sim2 distal configuration was reportedly used for vascular access.During the procedure, the distal sim2 tip segment reportedly separated from the catheter.Limited procedural details were available at the time of mdr submission despite follow-up attempts with the sales representative and physician.No additional information regarding the exact procedural sequence, resistance encountered, patient outcome, or retrieval details was available.Only the separated sim2 distal tip segment was returned for evaluation.Returned product analysis identified complete separation of the distal tip segment with measured elongation of approximately 4.5 cm relative to nominal manufactured length, consistent with significant tensile loading prior to separation.No evidence of manufacturing or material nonconformance was identified in the returned segment evaluation.The observed damage morphology was consistent with mechanical overstress encountered during clinical use.At the time of this report, no additional patient injury information had been provided.

• 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: 25191804
• Report Number: 3015614-2026-00016
• Device Sequence Number: 16035664
• Product Code: DQY
• UDI-Device Identifier: 00857545008158
• UDI-Public: 00857545008158
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG 01194-01
• Device Lot Number: FG250917C-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown