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	Insufficient Information (4580)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during preparation for a neurovascular procedure on (b)(6) 2026, a zebra 7f 95 cm sim2 catheter was removed from the product packaging and prepared for use.The scrub technician reportedly flushed the catheter while it remained within the protective tubing, and resistance was noted during flushing.After removal from the protective tubing, a distal shaft kink was reportedly observed.The customer reported that the device was not used for patient treatment, and an alternate device was utilized to complete the procedure successfully without reported patient injury or adverse clinical outcome.The device was returned to q'apel medical on 4/20/2026 and underwent product evaluation on 4/23/2026.The returned product evaluation identified findings that are inconsistent with the reported event description.Visual inspection identified a severe proximal shaft kink/fracture approximately 10-11 cm from the hub/strain relief.When flushing the central lumen, leakage from the fractured region confirmed a lumen breach.Additionally, blood was observed exiting the distal tip of the central lumen during flushing, suggesting the device may have been exposed to blood or introduced during procedural use.The condition of the returned device is not consistent with the initially reported distal shaft kink identified during preparation for use and not used for treatment, and the relationship between the returned damage and the originally reported event could not be definitively determined.The exact sequence of events, timing of damage occurrence, and device use status could not be definitively determined.No patient injury or adverse clinical outcome was reported.Q'apel continues to make good faith efforts to reconcile the event inconsistencies.This report will be supplemented if additional relevant information becomes available.

• 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: 25117588
• Report Number: 3015614-2026-00015
• Device Sequence Number: 10249585
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 06/10/2026

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: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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