BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLF THROMBECTOMY SYSTEM

    MDR report key: 17099415 · Received June 9, 2023

    Report

    Report Number
    2134265-2023-00058
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    March 31, 2023
    Report Date
    June 9, 2023
    Manufacturer
    DEVORO MEDICAL, INC
    Product Code
    QEW
    UDI-DI
    00850029546238
    PMA / PMN Number
    K210530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MFR: THE 7FR WOLF DEVICE AND TWO RELOAD SLEEVES WERE RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE WOLF DEVICE FOUND THAT THE CATHETER WAS KINKED AND BREAKING AT 104CM FROM THE STRAIN RELIEF. THE SLEEVE SHAFT ALSO SHOWED KINKING AT 124CM FROM THE BLACK PULL KNOB. THE RELOAD SLEEVES WERE UNUSED. THE CATHETER STARTED BREAKING AT THE KINK POINT DURING THE PRODUCT ANALYSIS. THE REPORTED EVENT OF KINKING OF THE CATHETER WAS CONFIRMED, AND ADDITIONALLY IT WAS FOUND THAT THE CATHETER WAS BREAKING AT THE KINK.

    Description of Event or Problem · 0

    REPORTABLE UPON ANALYSIS COMPLETED ON 22MAY2023. IT WAS REPORTED THAT THE CATHETER HAD KINKED. A 7FR WOLF ARTERIAL THROMBECTOMY CATHETER WAS SELECTED FOR USE. LEFT FEMORAL ACCESS WAS OBTAINED AND A GUIDE SHEATH WAS INSERTED OVER THE BIFURCATION INTO THE RIGHT COMMON FEMORAL ARTERY. A 7FR WOLF ARTERIAL THROMBECTOMY CATHETER WAS ADVANCED. UPON INGESTING THE CLOT USING A PIN AND PULL METHOD, RESISTANCE WAS OBSERVED. AFTER THE SLEEVE HAD CAPTURED THE CLOT, THE INNER CATHETER WAS ATTEMPTED TO BE REMOVED. HOWEVER, DURING REMOVAL THE SHAFT SNAPPED IN HALF. THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED. A SECOND DEVICE, SAME MODEL, WAS SELECTED FOR USE. THE REMAINING CLOT WAS SUCCESSFULLY REMOVED USING THIS CATHETER. UPON REMOVAL, IT WAS OBSERVED THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE AT THE KINKED AREA ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210997 WOLF THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW DEVORO MEDICAL, INC FD0427-04 0000200012 00850029546238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown