BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19239121 · Received May 3, 2024

    Report

    Report Number
    3014590708-2024-00017
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 6, 2024
    Report Date
    May 3, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 71 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 71. THE MANUFACTURING RECORDS FOR THE ZOOM 71 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. WITHOUT ANY CASE IMAGES AND BASED ON THE COMPLAINT INFORMATION PROVIDED, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED FOR AN OCCLUSION IN THE LEFT PROXIMAL MIDDLE CEREBRAL ARTERY/M1 SEGMENT. ACCESS WAS OBTAINED WITH A GUIDEWIRE, A MICROCATHETER, AND A TRACSTAR ACCESS CATHETER TO THE LEFT COMMON CAROTID ARTERY (CCA). DURING THE FIRST PASS, THE GUIDEWIRE AND THE MICROCATHETER WERE REMOVED AND A 0.035" GUIDEWIRE AND A ZOOM 71 CATHETER WERE ADVANCED THROUGH THE TRACSTAR TO THE LEFT CCA. A ZOOM 35 CATHETER WAS THEN ADVANCED THROUGH THE ZOOM 71 AND DURING ADVANCEMENT THE PHYSICIAN FELT RESISTANCE IN THE LEFT CCA. THE PATIENT'S ANATOMY DID NOT EXHIBIT TORTUOSITY, STENOSIS, OR CALCIFICATION. THE PHYSICIAN PROCEEDED TO REMOVE THE GUIDEWIRE, THE ZOOM 35, AND THEN THE ZOOM 71 WITHOUT PERFORMING ASPIRATION. UPON REMOVAL, THE PHYSICIAN NOTED THAT APPROXIMATELY 10 CM PORTION OF THE ZOOM 71 CATHETER HAD SEPARATED INSIDE THE TRACSTAR. THE PHYSICIAN RETRACTED THE SEPARATED ZOOM 71 AND TRACSTAR AS A SYSTEM. AFTER THE REMOVAL OF THE ZOOM 71 AND TRACSTAR DEVICES, A KINK WAS NOTED ON THE TRACSTAR. PER THE PHYSICIAN, THE KINK WAS NOT OBSERVED DURING THE CASE. THE PHYSICIAN PROCEEDED WITH THE CASE USING A NEW TRACSTAR AND ZOOM 71. AFTER ASPIRATION, THE CLOT WAS SUCCESSFULLY REMOVED, AND THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030317 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2328301 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0.035" COLOSSUS GUIDEWIRE| TRACSTAR