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

Model Number	087 BALLOON GUIDE CATHETER
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the limited information, q'apel medical is unable to confirm the reported event and determine if a product malfunction occurred.
Event or Problem Description
On 5/28/2024, q'apel medical received an email from the fda notifying the company of a voluntary mdr that was submitted on 5/5/2024.Per the reported problem statement: "cervical left internal carotid artery dissection at site of walrus balloon guide catheter inflation with contrast pooling in false lumen, creating fusiform dilation and requiring antiplatelet use (aspirin) to prevent thromboembolism.This occurred after mechanical thrombectomy for intracranial large-vessel occlusion (left middle cerebral artery occlusion).95-cm 8f walrus bgc." the location provided was the usa.No other information was provided in the report.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont 94538
• MDR Report Key: 19602376
• Report Number: 3015614180-2024-00008
• Device Sequence Number: 16972838
• Product Code: DQY
• UDI-Device Identifier: 00857545008028
• UDI-Public: 00857545008028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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 Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG8087--95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White