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

Model Number	FG 01504-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On january 23, 2026, q'apel medical became aware of an event involving a 7f 95 cm sim 2 zebra catheter during a mechanical thrombectomy procedure performed via right radial access.The catheter was prepared and flushed per the instructions for use and advanced to the high cervical internal carotid artery.Two thrombectomy passes were performed using adjunctive devices.Tici 3 revascularization was achieved.Upon withdrawal of the zebra catheter through the sheath, a partial shaft fracture was observed.No resistance or unusual manipulation was reported during use or removal.No device fragments were retained in the patient, and no additional medical intervention was required.The patient outcome was reported as stable.Returned product evaluation confirmed a catheter shaft breach approximately 19 cm from the distal tip, characterized by polymer jacket and liner separation.Microscopic and visual inspection of the damaged region identified no abnormal laser-cut tube (lct) strut pattern, pitch variation, or geometric irregularity.The distal tip showed no abnormalities.No evidence of manufacturing nonconformance, material defect, or systemic design deficiency was identified.
Additional Manufacturer Narrative
During the procedure, the zebra catheter was introduced through a 7f terumo slender sheath via right radial access.The physician initially attempted to use a 6f sofia catheter through the zebra; however, it would not exit and was withdrawn.The system was downsized to a 5f sofia 125 catheter.A marksman microcatheter and solitaire stent retriever were used for the first thrombectomy pass, which was unsuccessful.The system was then exchanged for a freeclimb and tenzing system advanced over an aristotle 18 guidewire, and a second pass was performed.No aspiration was performed through the zebra catheter.

• 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: 24411116
• Report Number: 3015614-2026-00007
• Device Sequence Number: 12232204
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 01504-01
• Device Catalogue Number: AC7087-095-20-S
• Device Lot Number: FG250825D-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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