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

Model Number	FG 01764-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a stroke thrombectomy procedure performed via femoral access, the physician observed separation at the hub-hypotube interface of a zebra catheter while preparing to perform a third pass with a stent retriever.The third pass was not performed.The stent retriever and zebra catheter were removed together to prevent further separation or potential fracture progression.No patient injury, prolonged procedure, or additional medical intervention was reported.The physician confirmed the patient outcome was stable.Evaluation of the returned device confirmed a fracture at the distal edge of the strain relief at the hub-hypotube interface.The damage was localized to the hub region.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 deformation morphology is consistent with mechanical overstress involving combined bending and torsional loading at the hub-hypotube interface.Despite the visible fracture, the central lumen was able to be flushed when the fractured region was temporarily covered, and no additional breaches were identified along the shaft.No evidence of material defect, manufacturing nonconformance, or systemic design deficiency was identified.

• 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: 24411081
• Report Number: 3015614-2026-00006
• Device Sequence Number: 5877981
• Product Code: DQY
• UDI-Device Identifier: 00857545008240
• UDI-Public: 00857545008240
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/22/2026

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 01764-02
• Device Catalogue Number: AC7087-105-20-B
• Device Lot Number: FG251003D-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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