BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 16921001 · Received May 12, 2023

    Report

    Report Number
    3014590708-2023-00014
    Event Type
    Death
    Date Received
    May 12, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 12, 2023
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030474
    PMA / PMN Number
    K210996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT YET BEEN RETURNED FOR FURTHER INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. AS THE DEVICE HAS NOT BEEN RETURNED AND WITH THE LIMITED CASE IMAGES PROVIDED, THE EXACT ROOT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THE TORTUOSITY AND INSERTION AND RETRACTION THROUGH A KINKED CATHETER CONTRIBUTED TO THE ZOOM 55 SEPARATION.

    Description of Event or Problem · 0

    88-YEAR-OLD FEMALE WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE LEFT M2 SEGMENT. ACCESS WAS OBTAINED USING A GUIDEWIRE AND A ZOOM 88 ACCESS CATHETER. THE PATIENT HAD A TORTUOUS LEFT COMMON CAROTID WITH A BIG LOOP. THE ZOOM 88 WAS ADVANCED OVER THE GUIDEWIRE TO THE HIGH CERVICAL SECTION OF THE INTERNAL CAROTID ARTERY (ICA) THROUGH A TIGHT BEND IN THE COMMON CAROTID ARTERY. THE GUIDEWIRE WAS REMOVED AND EXCHANGED WITH A MICROWIRE. A ZOOM 55 WAS INSERTED INTO THE ZOOM 88 OVER A THIRD-PARTY MICROCATHETER AND MICROWIRE. IT WAS NOTED DURING INSERTION THAT THE ZOOM 88 HAD A KINK AND TENSION/RESISTANCE WAS FELT. THE ZOOM 55, THIRD PARTY MICROCATHETER, AND A STENT RETRIEVER WERE NAVIGATED TO THE CLOT OVER THE MICROWIRE. THE STENT RETRIEVER WAS PLACED THROUGH THE MICROCATHETER, AND THE MICROCATHETER WAS REMOVED. AFTER APPROXIMATELY A THREE-MINUTE DWELL TIME, THE STENT RETRIEVER WAS PARTIALLY PULLED INTO THE ZOOM 55. WHILE RETRACTING THE STENT RETRIEVER AND ZOOM 55 THROUGH THE KINKED ZOOM 88, THE PHYSICIAN FELT RESISTANCE AND BELIEVES THAT THIS IS WHERE THE DISTAL END OF THE ZOOM 55 SEPARATED FROM THE CATHETER. IMAGING WAS COMPLETED AND SHOWED THE DISTAL END OF THE ZOOM 55 HAD SEPARATED AND WAS IN THE ICA TERMINUS. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE SEPARATED SEGMENT USING DIFFERENT STENT RETRIEVERS AND MULTIPLE ASPIRATION CATHETERS. DURING ONE OF THESE ATTEMPTS, A SIMILAR ISSUE OCCURRED WITH A THIRD-PARTY ASPIRATION CATHETER WHERE THAT CATHETER BECAME ELONGATED, ALSO LIKELY DUE TO THE TORTUOUS ANATOMY AND KINKED ZOOM 88. THE PHYSICIAN DETERMINED THAT THE SEPARATED SEGMENT OF THE ZOOM 55 WAS NOT FLOW LIMITING AND DECIDED NOT TO REMOVE IT. POST PROCEDURE A DECISION WAS MADE PER THE PATIENT'S LIVING WILL TO PLACE THE PATIENT ON COMFORT CARE FOLLOWING THE SEVERE STROKE. THE PATIENT PASSED AWAY FIVE DAYS AFTER THE PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DEATH TO THE PATIENT'S FAMILY WITHDRAWING CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032269 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC055137 F2230101 00812212030474

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female GLIDEWIRE 0.038".| SOLITAIRE STENT RETRIVER.| SYNCHRO 0.014" MIRCOWIRE.| TREVO 3X32MM STENT RETRIEVER.| VELOCITY MICROCATHETER.| ZOOM 71.| ZOOM 88 ACCESS CATHETER.