MAUDE Adverse Event Report: Q'APEL MEDICAL INC. ZEBRA; CATHETER, PERCUTANEOUS

Model Number	FG 01194-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
On january 13, 2026, q'apel medical received fda medwatch report (b)(4).The report was submitted in november 2025 regarding a neurological procedure reportedly performed in (b)(6) 2025 at butterworth hospital (grand rapids, mi).The medwatch narrative stated: "a vascular catheter was threaded through an aortic stent, and the catheter tip was sheared off and retained within stent after treatment." q'apel medical initiated follow-up efforts upon receipt of the medwatch report.Multiple good-faith attempts were made to contact the report author to obtain additional clinical details, including confirmation of the reported event, patient outcome, device identification (product name, lot number), and availability of the device for return evaluation.As of february 10, 2026, q'apel medical has not received a response to these follow-up requests.The device referenced in the medwatch report was not returned to q'apel medical.Therefore, no physical device evaluation, dimensional inspection, or failure analysis could be performed.Due to limited information provided in the medwatch report and the lack of response to follow-up attempts, q'apel medical was unable to confirm: the specific q'apel product involved (if any), the lot number, procedural details, patient outcome, whether retrieval intervention was required, or the exact failure mode.The complaint investigation was limited to review of the medwatch narrative provided by fda.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct an administrative omission in the initial report.The related medical device report number (b)(4) associated with the same event was not included in block h10 (related report number) of the original submission.The related report number has now been added.No additional information regarding the event has changed.
Event or Problem Description
On january 13, 2026, q'apel medical received fda medwatch report (b)(4).The report was submitted in november 2025 regarding a neurological procedure reportedly performed in (b)(6) 2025 at (b)(6).The medwatch narrative stated: "a vascular catheter was threaded through an aortic stent, and the catheter tip was sheared off and retained within stent after treatment." q'apel medical initiated follow-up efforts upon receipt of the medwatch report.Multiple good-faith attempts were made to contact the report author to obtain additional clinical details, including confirmation of the reported event, patient outcome, device identification (product name, lot number), and availability of the device for return evaluation.As of february 10, 2026, q'apel medical has not received a response to these follow-up requests.The device referenced in the medwatch report was not returned to q'apel medical.Therefore, no physical device evaluation, dimensional inspection, or failure analysis could be performed.Due to limited information provided in the medwatch report and the lack of response to follow-up attempts, q'apel medical was unable to confirm: the specific q'apel product involved (if any), the lot number, procedural details, patient outcome, whether retrieval intervention was required, or the exact failure mode.The complaint investigation was limited to review of the medwatch narrative provided by fda.

• 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: 24310486
• Report Number: 3015614-2026-00003
• Device Sequence Number: 5583441
• Product Code: DQY
• UDI-Device Identifier: 00857545008158
• UDI-Public: 00857545008158
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 01194-01
• Device Catalogue Number: AC6074-095-30
• Device Lot Number: FG250806C-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown