BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLF THROMBECTOMY SYSTEM

    MDR report key: 16503919 · Received March 8, 2023

    Report

    Report Number
    2124215-2023-10765
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    DEVORO MEDICAL, INC
    Product Code
    QEW
    UDI-DI
    00850029546238
    PMA / PMN Number
    K210530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: THE WOLF THROMBECTOMY SYSTEM OUTER CATHETER AND TWO INNER SLEEVES (ONE SLEEVE HAD A GUIDEWIRE THOUGH IT) WERE RETURNED FOR ANALYSIS ALONG WITH THE PACKAGE CARD WITH AN ADDITIONAL UNUSED RELOAD. VISUAL OBSERVATION IDENTIFIED NO OBVIOUS DAMAGE TO THE OUTER CATHETER, AND THE TOUCHY OPENED AND CLOSED APPROPRIATELY. MICROSCOPIC ANALYSIS OF THE SLEEVE (BEFORE FULL DECONTAMINATION) REVEALED THAT WEAVE APPEARED TO BE BUNCHED UP AND STACKED ON TOP OF ADJACENT WEAVE. THE BUNCHING UP OF THE WEAVE WAS OBSERVED WHERE THERE WAS LARGER AMOUNTS OF DRIED BLOOD AND SOME CLOT, AND THE SLEEVE APPEARED TO HAVE LOST SOME OF ITS SHAPE DUE TO THE BUNCHING. THE GUIDEWIRE WAS UNABLE TO BE EASILY REMOVED, YET THE CAUSE FOR THE GUIDEWIRE BEING STUCK WAS NOT ABLE TO BE DETERMINED. AFTER FULL DECONTAMINATION OF THE DEVICE WAS PERFORMED, THE GUIDEWIRE MOVED FREELY AND WAS REMOVED EASILY WITHOUT FURTHER ENTRAPMENT. ANOTHER GUIDEWIRE WAS PASSED THROUGH THE DEVICE AGAIN TO ENSURE PROPER WIRE MOVEMENT, AND THERE WERE NO FURTHER ISSUES IDENTIFIED WITH GUIDEWIRE MOVEMENT OR REMOVAL. THE REPORTED ALLEGATION OF GUIDEWIRE ENTRAPMENT WAS CONFIRMED, HOWEVER, THE OBSERVATIONS IDENTIFIED UPON ANALYSIS APPEAR TO BE RELATED TO DRIED BLOOD. IT REMAINS UNDETERMINED WHAT CAUSED THE DEVICE TO BECOME STUCK ON THE GUIDEWIRE DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF BLOOD FLOW TO THE FOOT. THE WOLF THROMBECTOMY SYSTEM WAS SELECTED TREATMENT OF THROMBOSIS OF LEFT LOWER EXTREMITY FEMORAL PERONEAL SYNTHETIC BYPASS GRAFT (PLACED IN 2019). THE WOLF WAS CHOSEN AFTER THE PATIENT PULLED OUT THE EKOS CATHETER PREMATURELY OVERNIGHT, FOLLOWED BY ASPIRATION THROMBECTOMY WITH A NON-BSC DEVICE AND SUBSEQUENT PLACEMENT OF A STANDARD THROMBOLYSIS CATHETER. THE PATIENT WAS BROUGHT BACK TO THE LAB AND ONCE THROMBOLYSIS CATHETER WAS REMOVED, PHYSICIAN CONFIRMED PATIENT HAD BLOOD FLOW IN THE PERONEAL AND INTO THE FOOT, HOWEVER, HAD A 25CM OCCLUSION IN THE PROXIMAL PORTION OF THE BYPASS GRAFT. DURING WOLF PLACEMENT, THE PHYSICIAN HAD COMPLETED THE FIRST SLEEVE PULL AND CONFIRMED WIRE MOVEMENT THROUGH THE INNER SHAFT. WHILE REMOVING, THE CATHETER AND INNER SHAFT/SLEEVE BECAME TIGHT AND UNABLE TO REMOVE WITHOUT LOSING WIRE. THE REMOVAL WAS STOPPED, AND THE CATHETER WAS PUSHED FURTHER DISTAL AND THEN REMOVING THE INNER SHAFT WITH THE NON-BSC WIRE TO RELOAD AND TRY AGAIN. ONLY MINIMAL CLOT WAS ABLE TO BE REMOVED, SO PHYSICIAN OPTED TO RUN TWO OTHER NON-BSC DEVICES WITH MINIMAL CLOT REMOVED. AS A RESULT, IT APPEARED THAT CLOT WAS IN THE PERONEAL AND WE LOST MOST OF THE FLOW TO THE FOOT. IT IS UNKNOWN WHETHER THIS WAS CAUSED WHEN USING THE WOLF CATHETER OR THE NON-BSC DEVICES. AS A RESULT, THE PHYSICIAN PLACED ANOTHER EKOS CATHETER INTO THE BYPASS GRAFT AND OPTED TO RUN OVERNIGHT AND RECHECK. FURTHER PATIENT OUTCOME WAS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136345 WOLF THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW DEVORO MEDICAL, INC FD0427-04 0000200012 00850029546238

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention ABBOTT HI TORQUE SPARTACORE GUIDEWIRE