BEUDAMED
    FDA Adverse Event Death Summary report: Y

    ZOOM REPERFUSION CATHETER

    MDR report key: 10833262 · Received November 12, 2020

    Report

    Report Number
    3014590708-2020-00005
    Event Type
    Death
    Date Received
    November 12, 2020
    Date of Event
    October 4, 2020
    Report Date
    November 12, 2020
    Manufacturer
    IMPERATIVE CARE INC
    Product Code
    NRY
    UDI-DI
    00812212030061
    PMA / PMN Number
    K202182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED; HOWEVER, THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. APPROPRIATE TESTING AND INSPECTION WERE COMPLETED TO ENSURE THE DEVICE TIP IS ATRAUMATIC, AND THE DISTAL SECTION OF THE CATHETER UNDERGOES 100% VISUAL INSPECTION AND IS FREE OF VISUAL DEFECTS OR PROTRUSIONS. AT THIS TIME, DUE TO THE LIMITED IMAGES AND INFORMATION AVAILABLE FROM THE HOSPITAL THE ROOT CAUSE OF THE VESSEL DISSECTION IS UNKNOWN, AND IT CANNOT BE DETERMINED IF ZOOM REPERFUSION CATHETER CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(6) TO TREAT OCCLUSION WITHIN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS. PATIENT HAD A FETAL POSTERIOR COMMUNICATING (PCOM) ARTERY PRESENT. THE ZOOM 088T 110CM CATHETER WAS DELIVERED TO THE OSTIUM OF THE FETAL PCOM. A TOTAL OF THREE PASSES WERE PERFORMED. THE FIRST TWO PASSES WERE MADE WITH ASPIRATION USING THE ZOOM 71 REPERFUSION CATHETER WHICH HAD ADVANCED TO THE MCA OVER A COMPETITOR MICROCATHETER AND GUIDEWIRE. THE MCA LOOKED IRREGULAR PRIOR TO THE THIRD PASS. THE THIRD PASS WAS PERFORMED WITH A COMPETITOR STENT RETRIEVER. UPON FINAL IMAGING RUN A DISSECTION WAS NOTED IN THE MIDDLE CEREBRAL ARTERY (MCA) AS WELL THE ICA. AT THE TIME OF THROMBECTOMY NO INTERVENTIONS OR FOLLOW UP TREATMENTS WERE SCHEDULED FOR THE PATIENT. IT IS NOT KNOWN IF THE ZOOM CATHETERS CAUSED OR CONTRIBUTED TO THE VESSEL DISSECTIONS. PATIENT EXPIRED THREE POST OPERATIVE DAYS ON (B)(6), AND THE RELATIONSHIP BETWEEN THE VESSEL DISSECTION AND THE PATIENT DEATH IS UNKNOWN. THE CAUSE OF PATIENT DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296147 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC ICRC071137 F2003401 00812212030061

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O