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

Model Number	FG 01195-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an mma embolization procedure performed via femoral access on (b)(6) 2026, resistance was reportedly encountered by the physician during withdrawal of a zebra 6f 95 cm catheter within tortuous iliac anatomy.The physician reported associated vessel spasm, after which the catheter reportedly kinked, twisted, and separated during removal attempts.The separated catheter segments were reportedly retrieved using a snare, and no fragments were reported to remain in the patient.The patient was reported to be stable following retrieval of the catheter segments.The product was returned in four shaft segments.Evaluation identified multiple fracture/separation locations.The combined segment lengths were consistent with the manufactured device length specification, and no significant elongation was identified.Visual and microscopic evaluation identified twisting, flattening, pinching, and localized compression damage across multiple regions of the catheter.The fracture morphology appeared torn and irregular, consistent with mechanical stress during device removal and retrieval.Feed gap spacing and reinforcement pattern were observed to be uniform throughout the evaluated regions.No evidence of abnormal reinforcement spacing, structural anomalies, or other manufacturing-related nonconformance was identified.Based on the available information, the reported event is most consistent with mechanical overstress during withdrawal through tortuous anatomy with resistance encountered during removal.

• 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: 25239303
• Report Number: 3015614-2026-00017
• Device Sequence Number: 9489972
• Product Code: DQY
• UDI-Device Identifier: 00857545008189
• UDI-Public: 00857545008189
• 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): 05/21/2026

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
• Device Model Number: FG 01195-01
• Device Catalogue Number: AC6074-095-20
• Device Lot Number: FG251010C-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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: Required Intervention
• Patient Sex: Unknown