BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM¿ REPERFUSION CATHETER

    MDR report key: 12845547 · Received November 19, 2021

    Report

    Report Number
    12845547
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 24, 2021
    Report Date
    November 4, 2021
    Manufacturer
    IMPERATIVE CARE, INC.
    Product Code
    NRY
    UDI-DI
    00812212030191
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REQUIRED AN ACUTE STROKE INTERVENTION SECONDARY TO AN OCCLUSION IN THE LEFT PROXIMAL BASILAR ARTERY. DURING THE PROCEDURE, A MINUTE CATHETER TIP FRAGMENT WAS EMBEDDED IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739447 ZOOM¿ REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE, INC. ICRC071137 F2126501 00812212030191

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Male Other