BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19536695 · Received June 14, 2024

    Report

    Report Number
    3014590708-2024-00019
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 13, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030474
    PMA / PMN Number
    K210996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 55 CATHETER WAS RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE REPORTED SHAFT BREAKAGE THAT OCCURRED AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED, STRETCHING THE SHAFT MATERIALS PRIOR TO BREAKING. INVESTIGATION DEMONSTRATED STRETCHING AND KINKING ALONG BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE BROKEN CATHETER SHAFT. STRETCHED CATHETER JACKET MATERIALS WERE OBSERVED ON BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE ZOOM 55. BASED ON THE COMPLAINT INFORMATION PROVIDED, WITH NO CASE IMAGES AND WITHOUT THE RETURN OF THE ADJUNCTIVE DEVICES, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THE ZOOM 55 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED FOR AN OCCLUSION IN THE M1 SEGMENT. THE PATIENT HAD A TYPE 1 ARCH, AND THE ANATOMY WAS NOT TORTUOUS. ACCESS WAS OBTAINED WITH A GUIDEWIRE AND A ZOOM 88 ACCESS CATHETER TO THE DISTAL PETROUS. DURING THE FIRST PASS, A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED, AND THE CLOT WAS REMOVED SUCCESSFULLY. POST ASPIRATION IMAGING REVEALED ANOTHER CLOT IN THE M2 SEGMENT. FOR THE SECOND PASS, THE SAME ZOOM 88 WAS ADVANCED AND PARKED IN THE PROXIMAL CAVERNOUS. THE SAME ZOOM 55 WAS ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT IN THE M2 SEGMENT. ASPIRATION WAS APPLIED BUT UNABLE TO ASPIRATE THE CLOT SUCCESSFULLY. A ZOOM 35 CATHETER WAS THEN ADVANCED THROUGH ZOOM 55. RESISTANCE WAS FELT WHEN ADVANCING THE ZOOM 35 THROUGH ZOOM 55. THE PHYSICIAN THEN NOTICED UNDER IMAGING THAT THE ZOOM 35 AND THE ZOOM 55 WERE NOT MOVING INDEPENDENTLY. THE ZOOM 55, ZOOM 35, AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. PER THE PHYSICIAN, THE DISTAL END AND THE SOFT PART OF THE ZOOM 55 WAS "ALL BUNCHED-UP". AFTER REMOVAL FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE ZOOM 35 FROM INSIDE OF THE ZOOM 55 AND FOUND THAT THE ZOOM 55 SHAFT HAD PARTIALLY SEPARATED AND WAS HELD TOGETHER BY "A THREAD". AT THE BACK TABLE, THE RESIDENT ATTEMPTED TO FLATTEN OUT THE "BUNCHED-UP" PORTION OF THE ZOOM 55, AND IN DOING SO, THE TWO PIECES BECAME DETACHED. IN THE THIRD PASS, THE GUIDEWIRE WAS ADVANCED THROUGH THE ZOOM 88 STILL IN PLACE AND A NEW ZOOM 55 WAS USED. THE PHYSICIAN ADVANCED THE SAME ZOOM 35 THROUGH THE NEW ZOOM 55. THE ZOOM 55 WAS THEN ADVANCED TO THE FACE OF CLOT IN THE M2 SEGMENT. THE CLOT WAS ASPIRATED SUCCESSFULLY WITHOUT ANY ISSUES. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393917 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC055137 F2406703 00812212030474

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female SYNCHRO STANDARD MICROWIRE| ZOOM 35| ZOOM 88