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

Model Number	FG 01764-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On january 27, 2026, q'apel medical became aware of an event involving a zebra 7f 95 cm bernstein catheter during an aneurysm embolization procedure performed via radial access.After selecting the right internal carotid artery and removing a 5f sim2 cook catheter, resistance was encountered while advancing a vecta 46, v17, and synchro through the zebra catheter.A 0.035" glidewire would not pass.A fracture was observed in vivo at approximately the distal one-third of the catheter.The device was gently withdrawn and remained intact during removal; however, complete separation occurred after exiting the sheath.The procedure was completed using an alternate catheter.No device fragments were retained in the patient.No vessel injury, dissection, perforation, embolization, vasospasm, additional intervention, or adverse clinical outcome was reported.The patient outcome was stable.Returned product evaluation confirmed a catheter shaft separation located approximately 19-20 cm from the distal tip at the jacket transition region.Microscopic examination demonstrated separation of the laser cut tube (lct) with inward collapse toward the lumen and associated polymer disruption.The fracture morphology was consistent with localized bending and tensile loading.No evidence of material defect, manufacturing nonconformance, or design anomaly 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: 24449289
• Report Number: 3015614-2026-00008
• Device Sequence Number: 10301169
• Product Code: DQY
• UDI-Device Identifier: 00857545008233
• UDI-Public: 00857545008233
• 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): 02/25/2026

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 01764-01
• Device Catalogue Number: AC7087-095-20-B
• Device Lot Number: FG250925D-05
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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