BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 17625082 · Received August 25, 2023

    Report

    Report Number
    3014590708-2023-00026
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    July 30, 2023
    Report Date
    August 25, 2023
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROXIMAL SEGMENT OF THE ZOOM 71 CATHETER WAS RETURNED FOR INVESTIGATION. INVESTIGATION DEMONSTRATED DAMAGE TO THE CATHETER SHAFT MATERIALS WHICH SUGGESTS THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE, STRETCHING THE SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. INVESTIGATION DEMONSTRATED STRETCHED COIL, AND OUTER JACKET AT THE BREAK LOCATION. THE DISTAL SEGMENT WAS NOT RETURNED. BASED ON THE IMAGING PROVIDED, THE DISTAL SEGMENT WAS OBSERVED TO HAVE A DEFORMED MARKER BAND AND A STRETCHED AND TANGLED CATHETER JACKET. THE EXACT ROOT CAUSE FOR THE BROKEN SHAFT COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THE ZOOM 71 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    AN 85-YEAR-OLD FEMALE WAS TREATED FOR AN OCCLUSION IN THE INTERNAL CAROTID ARTERY (ICA) TO THE TERMINUS. THE PATIENT'S ANATOMY WAS NOTED TO BE EXTREMELY TORTUOUS, AND THE OCCLUSION WAS SIGNIFICANT AND DENSE. ACCESS WAS OBTAINED WITH 0.014" GUIDEWIRE, THIRD-PARTY ACCESS CATHETER, AND THIRD-PARTY MICROCATHETER. THE ACCESS CATHETER WAS ADVANCED THROUGH THREE BENDS OF ICA TORTUOSITY WITHOUT ISSUE AND WAS POSITIONED AT THE CAVERNOUS SEGMENT. A THIRD PARTY MICROCATHETER WAS ADVANCED TO THE ICA. DURING THE FIRST PASS, THE ZOOM 71 ASPIRATION CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER AND OVER THE MICROCATHETER TO THE FACE OF THE CLOT IN THE ICA. THE TREATING PHYSICIAN REPORTED THE ZOOM 71 "FELT TIGHT" BEFORE THE TERMINUS OF THE ICA. ASPIRATION WAS APPLIED. UPON RETRACTION MULTIPLE "LARGE DENSE CHUNKS" OF CLOT WERE OBSERVED AT THE TIP OF THE ZOOM 71. WHILE REMOVING THE GUIDEWIRE, MICROCATHETER, AND THE ZOOM 71, THE PHYSICIAN FELT THE ZOOM 71 GET PARTIALLY STUCK IN THE ANTERIOR GENU, NEAR THE CAROTID TERMINUS ADJACENT TO THE OPHTHALMIC. ACCORDING TO THE PHYSICIAN, THE DISTAL PORTION OF THE ZOOM 71 HAD PARTIALLY SEPARATED AND BECAME LODGED IN THE ROTATING HEMOSTATIC VALVE (RHV). THE PHYSICIAN BELIEVED THE DISTAL PORTION OF THE ZOOM 71 HAD SEPARATED WITHIN THE ACCESS CATHETER. BOTH THE ZOOM 71 CATHETER AND THE SEPARATED SHAFT WERE SUCCESSFULLY REMOVED WITH THE RHV. THE TREATING PHYSICIAN NOTED THAT THE ACCESS CATHETER HAD BECOME OBSTRUCTED BY THE CLOT. THE ACCESS CATHETER WAS RETRACTED FROM THE CAROTID TO ASPIRATE THE DENSE, DARK BLACK CLOT. IN THE SECOND PASS, THE SAME THIRD-PARTY ACCESS CATHETER WAS ONCE AGAIN ADVANCED INTO THE TORTUOUS ICA. A THIRD-PARTY ASPIRATION CATHETER WAS ADVANCED TO THE CLOT LOCATED AT THE INFERIOR M2 SEGMENT AND ASPIRATION WAS APPLIED. THE CLOT WAS REMOVED SUCCESSFULLY. THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2C SCORE AND WAS REPORTED TO BE IN STABLE CONDITION. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919178 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2312201 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female INFINITY GUIDE CATHETER| RED 68 ASPIRATION CATHETER| ROTATING HEMOSTATIC VALVE (RHV)| SYNCHRO 0.014" GUIDEWIRE| VELOCITY MICROCATHETER