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

Model Number	FG 01504-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a right radial access to right carotid artery stenting procedure, sequential pre-dilation was performed using a 5f short sheath followed by a 6f short sheath.A 7f zebra sim2 catheter was then introduced without the use of an introducer sheath.A spider filter was advanced and positioned just beyond the first bend in the petrous segment.A contego carotid stent was successfully delivered and deployed with support from the zebra catheter.During retrieval of the stent and spider filter system, difficulty was encountered when the filter wire appeared to kink, preventing proper capture within the retrieval sheath.The damaged wire was subsequently pulled through the deployed stent, and resistance was noted when all components were withdrawn through the zebra catheter.A contrast run was then performed to confirm procedure completion.Upon subsequent removal of the zebra catheter, additional resistance was encountered, and a separation of the catheter occurred outside of the patient.The catheter was successfully removed in it's entirety.There was no adverse impact to the deployed stent, and no patient harm or clinical complications were reported.At the time of this initial report, the device had not been returned to the manufacturer for evaluation.If the device is returned and further information becomes available, a supplemental report will be issued.Based on the complaint details and procedural context, the failure is most consistent with use-related factors-specifically, excessive mechanical force during advancement against resistance-rather than a device defect.This is consistent with the zebra catheter's instructions for use (ifu), which caution that manipulation against resistance may result in damage to the vessel or the device.

• 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: 23373135
• Report Number: 3015614-2025-00008
• Device Sequence Number: 8879617
• Product Code: DQY
• UDI-Device Identifier: 00857545008226
• UDI-Public: 00857545008226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Operator of Device: Health Professional
• Device Model Number: FG 01504-02
• Device Catalogue Number: AC7087-105-20-S
• Device Lot Number: FG250910D-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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