MAUDE Adverse Event Report: Q'APEL MEDICAL WALRUS 087 BALLOON GUIDE CATHETER; CATHETER INTRODUCER

Model Number	087 BALLOON GUIDE CATHETER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Retroactive reporting to the fda of an incident that occured in the uk market on 4/21/2023.Q'apel medical became aware of the incident on 5/9/2024.Q'apel medical filed an initial mir report on 5/18/2023.Q'apel medical filed a final mir report on 6/8/2023.Conclusion: an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.The device did not malfunction.Physician had assessed that this patient would be very prone to vessel spasm.Physician believes there was some spasm during delivery which caused a small dissection.Imaging shows that the balloon never passed the site of dissection, so it was likely guide wire related.As a remedial action, the physician had administered 500mg of aspirin intravenously and waited 20 minutes before being satisfied that the issue had resolved.The dissection was not visible on the cta the next day.Additional information about the patient: age of patient - 40; gender - male; onset - 17:45; 1st run - 22:05; location of clot - left m1/m2; nihss - 8/21.Sheath - 9f cordis avanti+ intermediate - red 62.Stentriever - solitaiate 4x40.Tici score - 3.Patient and procedure outcome: 500mg iv aspirin given and waited approx 20 mins before issue had resolved (non-flow limiting so no need for a carotid stent.) tici score - 3.
Additional Manufacturer Narrative
In an email sent by the q'apel sale rep, (b)(6) on 5/11/2023 (see attached): "balloon inflation (this shows dissection just distal to position of balloon).".".The balloon never passed the site of dissection so likely to be guidewire related ".The investigation determined that the dissection wasn't due to balloon inflation.The physician had assessed that the patient would be very prone to vessel spasms and believed that there was some spasm during delivery which caused a small dissection.It was not flow-limiting.This is a known and industry-accepted risk in catheter delivery in the neurovasculature space.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): Q'APEL MEDICAL; 4245 technology drive; fremont CA 94538
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 46708 lakeview blvd.; fremont CA 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont, CA 94538
• MDR Report Key: 18862161
• Report Number: 3015614180-2024-00001
• Device Sequence Number: 20892870
• Product Code: DQY
• UDI-Device Identifier: 00857545008028
• UDI-Public: 00857545008028
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192525
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2025
• Device Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG8087-095
• Device Lot Number: FG220602J-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2022
• 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 Age: 40 YR
• Patient Sex: Male