MAUDE Adverse Event Report: Q'APEL MEDICAL INC. 072 ASPIRATION SYSTEM; CATHETER, THROMBUS RETRIEVER,

Model Number	FG 00806-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	12/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Retrospective filing for an event that occurred 12/31/2023.Information was obtained while reviewing data from q'apel' s retrospective cohort study with hippo.Follow up information was obtained by q'apel medical from the operator of the device on 1/16/2025 which stated: "hippo advanced to m1 for thrombectomy and follow up run shows vasospasm.I reviewed imaging.After 1st pass there is minimal vasospasm i would have to say likely caused by hippo (vasospasm i dont think it was clinically significant in review however the operator administered 8 mg verapamil to treat the vasospasm.Final tici score was 2c".Vessule occluded-lmca m1, first pass tici score-0, final pass tici score-2c.Reported devices involved in the procedure: zoom 88, hippo, zoom 71, zoom 35, zoom pod.

• Brand Name: 072 ASPIRATION SYSTEM
• Common Device Name: CATHETER, THROMBUS RETRIEVER,
• 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: 21284834
• Report Number: 3015614180-2025-00001
• Device Sequence Number: 9320542
• Product Code: NRY
• UDI-Device Identifier: 00857545008097
• UDI-Public: 00857545008097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222786
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: FG 00806-02
• Device Catalogue Number: AP6072-132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 51 YR
• Patient Sex: Male