BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 11886573 · Received May 26, 2021

    Report

    Report Number
    3014590708-2021-00007
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 26, 2021
    Manufacturer
    IMPERATIVE CARE INC
    Product Code
    NRY
    UDI-DI
    00812212030191
    PMA / PMN Number
    K210996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS NOT YET PROVIDED CONFIRMATION IF THE DEVICE IS AVAILABLE FOR RETURN. THE MANUFACTURING RECORDS FOR THIS LOT DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. ALL LOT ACCEPTANCE ACTIVITIES HAVE BEEN MET, AND APPROPRIATE SAMPLING AND INSPECTION WAS COMPLETED TO ENSURE THE DEVICES IN THE LOT MET SPECIFICATIONS. AT THIS TIME, WITHOUT RETURN OF THE DEVICE, LIMITED IMAGES AND INFORMATION AVAILABLE FROM THE HOSPITAL, THE ROOT CAUSE OF TIP SEPARATION IS UNKNOWN. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A STROKE CASE WITH BASILAR OCCLUSION. ACCESS WAS OBTAINED WITH A COMPETITOR ACCESS CATHETER UTILIZING A RADIAL APPROACH. THE ZOOM 71 WAS ADVANCED TO THE TARGET CLOT LOCATION WITH A COMPETITOR MICROCATHETER AND 0.014" GUIDEWIRE, BUT WAS WEDGED INTO THE DISEASED PLAQUE IN THE VERTEBRAL ARTERY. WHILE ATTEMPTING TO PULL OUT THE ZOOM 71 THE OPERATOR ENCOUNTERED RESISTANCE, AND UPON FURTHER RETRACTION THE ZOOM 71 RELEASED. INSPECTION OF THE REMOVED ZOOM 71 RESULTED IN THE TIP BEING OBSERVED AS SEPARATED. THE OPERATOR ATTEMPTED TO RETRIEVE THE SEPARATED TIP WITH A COMPETITOR STENT RETRIEVER AND WAS UNSUCCESSFUL. THE OPERATOR THEN ATTEMPTED TO ADVANCE A COMPETITOR INTERMEDIATE CATHETER WITH A NEW ACCESS CATHETER AND MICROCATHETER, BUT WAS ALSO UNABLE TO NAVIGATE TO THE SITE OF THE OCCLUSION. THE CASE WAS CONCLUDED AFTER USE OF THE COMPETITOR INTERMEDIATE CATHETER. THE PATIENT STATUS IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782672 ZOOM REPERFUSION CATHETER CATEHTER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC ICRC071137 F2104102 00812212030191

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention