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

Model Number	FG 01504-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a right radial access to left carotid artery stenting procedure, the physician used a 6f sheath and a select catheter to access the carotid artery.After successful dilation, the physician exchanged the system for a 7f zebra catheter, removing the 6f sheath.The carotid stent was successfully placed.Upon removal of the 7f zebra catheter, the physician encountered resistance at the radial artery, noting a likely vasospasm.Upon continuing withdrawal of the device, the catheter separated outside the patient.A subsequent attempt to remove the remaining segment resulted in a second external break, after which the remaining catheter was fully retrieved.Fluoroscopic imaging confirmed no retained fragments or arterial damage.The access site was closed with a tr band.The patient remained stable and experienced no complications.The device was returned and received by the manufacturer, consisting of three catheter segments with no missing portions identified.Failure analysis of the reported event was performed.The returned zebra 7f catheter fractured in two locations, exhibiting clear signs of stretching along multiple fracture sites as a result of excessive pulling force applied during withdrawal against vessel resistance.The investigation did not identify any design, material, or manufacturing deficiencies contributing to the event.The observed failure was most consistent with procedural or use-related factors (e.G., radial artery vasospasm and traction during withdrawal) rather than a device defect.Based on the complaint details, procedural context, and visual findings, the most probable cause of the fracture is excessive mechanical force or torquing during advancement against resistance.This aligns with the zebra catheter's instructions for use (ifu), which caution that manipulation or torquing against resistance may result in damage to the vessel or device.

• Brand Name: ZEBRA
• Common Device Name: Catheter, percutaneous
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 4245 technology drive; fremont CA
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont, CA
• MDR Report Key: 23373159
• Report Number: 3015614-2025-00007
• Device Sequence Number: 15732953
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/23/2025

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
• Device Expiration Date: 01/11/2026
• Device Model Number: FG 01504-01
• Device Catalogue Number: AC7087-095-20-S
• Device Lot Number: FG250714D-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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