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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a radial access procedure, the physician observed blood escaping from the hub of a zebra catheter during use.The device was removed and replaced with another zebra catheter, allowing the procedure to be completed without further incident.A customer-provided image taken at the time of the event showed the catheter intact in one piece with a localized surface discontinuity (fracture) just distal to the strain relief.The user reported that no resistance or torquing was encountered during use.Evaluation of the returned device showed that the catheter was fractured just distal to the strain relief (1-2 mm), a location that experiences elevated mechanical stress when subjected to tight-radius bending or off-axis loading.No evidence of design or manufacturing nonconformance (e.G., improper lamination, abnormal feed gap, exposed reinforcement, or structural 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: 24076640
• Report Number: 3015614-2026-00001
• Device Sequence Number: 10482802
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/14/2026

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: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (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