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 Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Retrospective filing for an event that ocured 5/2/2024.The case was reported by q'apel medical's chief marketing officer who was present for the case and reported the findings.The initial review by q'apel medical's medical physican and "qualified person" determined that the q'apel device did not contribute to the injury and therefore, the event was not reportable.New information was obtained by q'apel medical from the operator of the device on 1/15/2025 which stated: "there is no fluoro loop of the 2nd pass hippo navigating up to the clot.There is one of the first pass and it navigated smoothly with no wire issues.I can not imagine how that amount of extravasation occurred from a microwire perforation." the new information concluded that the q'apel medical device likely contrinuted to the injury that required medical intervention.Case date:(b)(6) 2024.78 yo [year old] female patient.Stroke case r m1 occlusion.3.5 since lkw.No tnk or tpa administered due to a fall.Walrus bgc used as guide.1 pass with hippo cheeath with an aristotle 18 gw.Result was tici 0.2nd pass with hippo cheetah and aristotle 18 gw.On run post aspiration, vessel rupture with contrast extravasation vitals remained stable for patient and no loss of pressure.Scepter balloon placed at site to arrest bleed for 5 min.Bleeding controlled.No other intervention to control this required.3rd pass - zoom 55.Tici 0.4th pass - zoom 55 tici 0.5th pass - velocity mc and tigertriever 32mm deployed for 2 mins - tici 0.6th pass - zoom 55 - tici 0.

• 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: 21284855
• Report Number: 3015614180-2025-00002
• Device Sequence Number: 15791633
• 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 Expiration Date: 06/19/2024
• Device Model Number: FG 00806-02
• Device Catalogue Number: AP6072-132
• Device Lot Number: FG231222A-01
• 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: 05/02/2024
• 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: Female