BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 20098261 · Received August 29, 2024

    Report

    Report Number
    3014590708-2024-00031
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 29, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. THE EXACT ROOT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED AS THE DEVICE AND ADJUNCT DEVICES WERE NOT RETURNED FOR INVESTIGATION, AND THERE WAS LIMITED INFORMATION PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION BUT UNSUCCESSFUL. BASED ON THE INFORMATION PROVIDED, THE ZOOM 71 WAS USED TO TREAT AN OCCLUSION IN THE A2 (ANTERIOR CEREBRAL ARTERY) SEGMENT. PER THE INSTRUCTION FOR USE, THE ZOOM DEVICES ARE INDICATED FOR USE, "...(WITHIN THE INTERNAL CAROTID, MIDDLE CEREBRAL - M1 AND M2 SEGMENTS, BASILAR, AND VERTEBRAL ARTERIES) WITHIN 8 HOURS OF SYMPTOM ONSET."

    Description of Event or Problem · 0

    A PATIENT WAS TREATED FOR AN A2 (ANTERIOR CEREBRAL ARTERY) OCCLUSION. ACCESS WAS OBTAINED WITH A TRACSTAR ACCESS CATHETER. DURING THE FIRST TWO PASSES, A THIRD-PARTY MEDIUM ASPIRATION CATHETER AND A THIRD-PARTY SMALL ASPIRATION CATHETER WERE ADVANCED THROUGH THE TRACSTAR, AND ASPIRATION WAS PERFORMED. AFTER ASPIRATION, BOTH THIRD-PARTY ASPIRATION CATHETERS WERE REMOVED FROM THE PATIENT AND CONTRAST WAS APPLIED THROUGH THE TRACSTAR ACCESS CATHETER. ON THE THIRD PASS, A THIRD-PARTY MEDIUM ASPIRATION CATHETER (IT IS UNCLEAR IF IT WAS THE SAME ONE USED IN THE FIRST TWO PASSES), A MICROCATHETER, AND A STENT RETRIEVER WERE ADVANCED THROUGH THE SAME TRACSTAR CATHETER. AFTER ASPIRATION, THE THIRD-PARTY MEDIUM ASPIRATION CATHETER, THE MICROCATHETER, AND THE STENT RETRIEVER WERE REMOVED FROM THE PATIENT. DURING THE FOURTH PASS, A ZOOM 71 ASPIRATION CATHETER, A DIFFERENT THIRD-PARTY MICROCATHETER, AND A STENT RETRIEVER (IT IS UNCLEAR IF IT WAS THE SAME STENT RETRIEVER USED IN THE THIRD PASS) WERE ADVANCED THROUGH THE SAME TRACSTAR CATHETER. THE ZOOM 71 WAS POSITIONED IN THE A1 SEGMENT WHILE THE STENT RETRIEVER WAS ADVANCED TO THE CLOT IN THE A2 SEGMENT. UPON RETRACTING THE STENT RETRIEVER, THE ZOOM 71 MOVED INTO THE A2 SEGMENT. RESISTANCE WAS ENCOUNTERED DURING THIS PASS, AND IT WAS NOTED THAT A DISTAL SEGMENT OF THE ZOOM 71 HAD SEPARATED. THE PHYSICIAN USED THE STENT RETRIEVER TO SUCCESSFULLY CAPTURE THE SEPARATED PIECE OF THE ZOOM 71 AND REMOVED IT FROM THE PATIENT. NO FURTHER PASSES WERE ATTEMPTED AND, THE A2 SEGMENT REMAINED OCCLUDED. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313824 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention RED 43.| RED 62.| TRAC21.| TRACSTAR.| TREVO.| VELOCITY.