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	Insufficient Information (4580)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a neurovascular procedure performed on (b)(6) 2026 via right radial access, a zebra 7f 95 cm sim2 catheter was reportedly advanced through tortuous anatomy involving a sharp innominate artery takeoff.Resistance was reportedly encountered during advancement and withdrawal.During removal, a kink was reportedly observed along the distal shaft of the catheter.While withdrawing the device, the catheter reportedly separated near the proximal shaft region, resulting in separation into two pieces.The distal catheter segment reportedly remained partially within the patient vasculature and was physician intervention was required to remove the retained catheter segment from the patient vasculature.The physician reportedly re-accessed the patient and completed the procedure successfully using a different catheter.The patient outcome was reported stable post-procedure.The returned device was received for evaluation in two separated pieces.Visual examination confirmed catheter separation approximately 2.5 cm distal to the strain relief.The returned catheter length was consistent with manufactured specification and no significant elongation was identified.Additional shaft bends/deformations were observed approximately 47 cm and 72 cm from the proximal end of the distal separated segment.Due to the returned packaging configuration and post-use handling condition, it could not be conclusively determined whether these deformations originated during clinical use or subsequent return handling.The damage observed is consistent with deformation associated with coiling/bending of the device during return packaging.Microscopic evaluation observed cut pattern spacing consistent with specification without evidence of structural irregularities, material defects, or other manufacturing nonconformance's adjacent to the separation region.The fracture morphology appeared irregular/torn without evidence of localized inward compression, crushing, or abnormal reinforcement deformation.Based on the available information, the investigation results support a mechanical loading/use-related failure mechanism associated with advancement and withdrawal through tortuous anatomy with procedural resistance.

• 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: 25280527
• Report Number: 3015614-2026-00018
• Device Sequence Number: 15973996
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: FG260218D-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown