BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 11563340 · Received March 24, 2021

    Report

    Report Number
    3014590708-2021-00006
    Event Type
    Death
    Date Received
    March 24, 2021
    Date of Event
    February 20, 2021
    Report Date
    March 23, 2021
    Manufacturer
    IMPERATIVE CARE INC
    Product Code
    NRY
    PMA / PMN Number
    K202182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT COULD NOT BE IDENTIFIED OR REVIEWED AS THE DEVICE AND ITS PACKAGING MATERIAL WERE DISCARDED DURING THE CASE. ALL PRODUCT IS SUBJECTED TO TESTING AND INSPECTION 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. POTENTIAL ADVERSE EVENTS RELATED TO ZOOM REPERFUSION CATHETERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTRACRANIAL HEMORRHAGE, VESSEL SPASM, DISSECTION, PERFORATION, RUPTURE, INCLUDING DEATH. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, OUTSTANDING QUALITY OR MANUFACTURING ISSUE, OR USER MISUSE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(3) TO TREAT OCCLUSION WITHIN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS. ACCESS WAS OBTAINED WITH A TRACSTAR 105 CM AT THE OPHTHALMIC SEGMENT OF THE ICA. AFTER ONE PASS WITH A ZOOM 71 REPERFUSION CATHETER IN ICA TERMINUS ACHIEVING A TICI SCORE OF 2A, THE PHYSICIAN OBSERVED THAT THERE WAS ANOTHER OCCLUSION IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). ONE PASS WAS PERFORMED ON THE M2 MCA SEGMENT USING THE SAME ZOOM 71. THERE WERE NO INTERMEDIATE CATHETERS OR GUIDEWIRES USED IN EITHER THE ICA TERMINUS OR M2 MCA CLOT RETRIEVAL ATTEMPTS. THE PHYSICIAN NOTICED A PERFORATION IN THE M2 MCA AFTER REMOVING THE CLOT, AND EXTRAVASATION DUE TO PERFORATION. THE PHYSICIAN REVIEWED THE PROCEDURAL IMAGING POST-PROCEDURE AND NOTED THAT THE LOCATION OF THE M2 PERFORATION WAS DISTAL TO THE SITE OF THE CLOT AND END OF THE CATHETER. EMBOLIC COILS WERE USED AFTER THE PERFORATION AS AN INTERVENTION. THE FAMILY DID NOT WANT TO PERFORM ADDITIONAL INTERVENTION AFTER THE INITIAL STROKE PROCEDURE. THE PATIENT EXPIRED POST ONE OPERATIVE DAY IN THE MORNING, WITH CAUSE OF DEATH LISTED AS STROKE AND HEMORRHAGE. PHYSICIAN DID NOT ATTRIBUTE THE DEATH TO PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460108 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC ICRC07137

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| R