BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 14628763 · Received June 7, 2022

    Report

    Report Number
    3014590708-2022-00011
    Event Type
    Death
    Date Received
    June 7, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 7, 2022
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 71. THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. ALL DEVICES UNDERGO TESTING AND INSPECTION CONFIRMING DEVICES MEET SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE INFORMATION PROVIDED, ASPIRATION THROUGH THE ZOOM 71 WAS PERFORMED AS INTENDED. VIDEO OF THE PROCEDURE SHOWED THE GUIDEWIRE POSITIONED DISTAL OF THE ZOOM 71, WITH ITS TIP DOUBLED BACK TO THE CAVERNOUS ICA. DUE TO THE AMOUNT OF DOUBLE BACK OF THE WIRE, THE PART OF THE WIRE IN THE M1 MAY HAVE BEEN A STIFFER SECTION THAN THE TIP OF THE WIRE. THE BLEEDING OBSERVED ON THE CASE IMAGE WAS IN A LOCATION THAT THE WIRE WAS PLACED AND DISTAL TO THE PLACEMENT OF THE ZOOM 71. THE PHYSICIAN REPORTED THAT THE BLEEDING WAS FROM A LENTICULOSTRIATE ARTERY. BASED ON THIS INFORMATION AND VIDEO PROVIDED, THE CAUSE OF THE VESSEL DAMAGE AND SUBSEQUENT BLEEDING DISTAL TO THE FURTHERMOST LOCATION THE ZOOM 71 WAS PLACED IS UNKNOWN.

    Description of Event or Problem · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 71. THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. ALL DEVICES UNDERGO TESTING AND INSPECTION CONFIRMING DEVICES MEET SPECIFICATIONS PRIOR TO RELEASE. THE EXACT CAUSE OF THE VESSEL DAMAGE AND SUBSEQUENT BLEEDING IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, ASPIRATION THROUGH THE ZOOM 71 WAS PERFORMED AS INTENDED. VIDEO OF THE PROCEDURE SHOWED THE GUIDEWIRE POSITIONED DISTAL OF THE ZOOM 71, WITH ITS TIP DOUBLED BACK TO THE CAVERNOUS ICA. DUE TO THE AMOUNT OF DOUBLE BACK OF THE WIRE, THE PART OF THE WIRE IN THE M1 MAY HAVE BEEN A STIFFER SECTION THAN THE TIP OF THE WIRE. THE BLEEDING OBSERVED ON THE CASE IMAGE WAS IN A LOCATION THAT THE WIRE WAS PLACED AND DISTAL TO THE PLACEMENT OF THE ZOOM 71. THE PHYSICIAN REPORTED THAT THE BLEEDING WAS FROM A LENTICULOSTRIATE ARTERY. BASED ON THIS INFORMATION AND VIDEO PROVIDED, IT IS UNLIKELY THE ZOOM 71 CAUSED THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412354 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Life Threatening FANTHOM 16 WIRE| ZOOM 88