BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19745960 · Received July 15, 2024

    Report

    Report Number
    3014590708-2024-00021
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    July 25, 2022
    Report Date
    July 15, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 71. BASED ON THE INFORMATION PROVIDED AND WITHOUT CASE IMAGES, THE EXACT CAUSE OF THE VESSEL PERFORATION IS UNKNOWN. THE RELATIONSHIP WITH THE ZOOM 71 DEVICE TO THE VESSEL PERFORATION COULD NOT BE ESTABLISHED. IT IS UNCLEAR IF THE PERFORATION WAS CAUSED BY THE ZOOM 71 DEVICE OR OTHER DEVICES. 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

    A PATIENT WAS TREATED FOR AN OCCLUSION IN THE RIGHT M1 SEGMENT. CT SCAN REVEALED AN EXTREMELY DENSE AND CALCIFIED CLOT. A THIRD-PARTY INSERT CATHETER AND ZOOM 88 ACCESS CATHETER WERE INTRODUCED OVER A GLIDEWIRE AND THE SYSTEM WAS ADVANCED OVER THE AORTIC ARCH AND INTO THE CERVICAL REGION. THE THIRD-PARTY INSERT CATHETER WAS THEN REMOVED. A ZOOM 71 ASPIRATION CATHETER WAS NAVIGATED OVER A THIRD-PARTY MICROCATHETER AND MICROWIRE THROUGH THE ZOOM 88. THE ZOOM 71 ASPIRATION CATHETER WAS ADVANCED INTO THE M1 SEGMENT TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 71. AFTER THREE PASSES, NO MEANINGFUL REPERFUSION WAS ACHIEVED. DURING THE FOURTH PASS, THE PHYSICIAN ADVANCED THE SAME ZOOM 71 OVER THE SAME THIRD-PARTY MICROCATHETER AND MICROWIRE TO THE FACE OF THE CLOT. THE PHYSICIAN THEN CROSSED THE CLOT WITH THE THIRD-PARTY MICROCATHETER AND MICROWIRE, GOING OUT THE SUPERIOR TRUNK OF THE MIDDLE CEREBRAL ARTERY (MCA). THE MICROWIRE WAS REMOVED AND A STENT RETRIEVER WAS ADVANCED THROUGH THE MICROCATHETER. THE STENT RETRIEVER WAS DEPLOYED ALONG THE ENTIRE M1 SEGMENT. THE ZOOM 71 WAS THEN POSITIONED TO ENSURE IT WAS AT THE FACE OF THE CLOT, TRAPPING THE CLOT BETWEEN THE STENT RETRIEVER AND THE ASPIRATION CATHETER. THE PHYSICIAN REMOVED THE ZOOM 71 AND STENT RETRIEVER SIMULTANEOUSLY UNDER ASPIRATION. INTERMITTENT ANGIOGRAPHY DEMONSTRATED TICI 2A RECANALIZATION. ACTIVE EXTRAVASATION WAS SUSPECTED, THE PHYSICIAN ADVANCED THE SAME THIRD-PARTY MICROCATHETER AND DEPLOYED A 3.5 MM X 10 CM EV3 COIL IN THE DISTAL RIGHT M1 SEGMENT. INTERMITTENT ANGIOGRAPHY WAS PERFORMED THAT DEMONSTRATED REDUCTION IN EXTRAVASATION WITHOUT SIGNIFICANT IMPACT ON DISTAL MCA PERFUSION. THE PHYSICIAN OBSERVED FLOW IN THIS TERRITORY WITH THE COIL IN PLACE FOR APPROXIMATELY 5 MINUTES BEFORE REMOVING IT. ANGIOGRAPHY WAS PERFORMED, AND NO FURTHER EXTRAVASATION NOTED. ALL THE CATHETERS WERE REMOVED. THERE WERE NO DEVICE ISSUES AND NO OTHER PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500872 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2213602 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention 3.5 MM X 10 CM EV3 AXIUM PRIME COIL| 5F VTK| SOLITAIRE STENT RETRIEVER| SYNCHRO GUIDEWIRE| VELOCITY MICROCATHETER| ZOOM 88