BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM¿ 88 LARGE DISTAL PLATFORM

    MDR report key: 14877123 · Received June 30, 2022

    Report

    Report Number
    3014590708-2022-00012
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 30, 2022
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    QJP
    UDI-DI
    00812212030337
    PMA / PMN Number
    K212224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE RETRACTION WAS REPORTED AS HARDER THAN NORMAL BASED ON HAVING TO PULL THROUGH THE PATIENT'S TORTUOUS ANATOMY. THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE TRACSTAR. THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. ALL DEVICES UNDERGO TESTING AND INSPECTION CONFIRMING DEVICES MEET SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A VENOUS STENTING CASE. UPON COMPLETION OF THE CASE AND DURING RETRACTION, THE DISTAL PORTION OF THE TRACSTAR GOT CAUGHT ON THE PREVIOUSLY DEPLOYED STENT AND BROKE SEVERAL CENTIMETERS FROM THE DISTAL END OF THE CATHETER IN THE INTERNAL JUGULAR. THE PATIENT REPORTEDLY HAD A VERY ZIG-ZAG TORTUOUS ANATOMY. THE DISTAL PORTION OF THE CATHETER WAS RETRIEVED WITH A SNARE. PATIENT WAS REPORTED TO BE DOING FINE AND NO COMPLICATIONS WERE REPORTED. THE PHYSICIAN DID NOT REPORT ANY ISSUES WITH THE TRACSTAR. DURING FOLLOW-UP, THE PHYSICIAN INFORMED THAT THE SHORT SHEATH WAS IN THE "Z" OR ZIG-ZAG SHAPE IN THE BODY AS A FACTOR FOR THE TRACSTAR SHAFT BEING BROKEN. THE RETRACTION WAS HARDER THAN NORMAL BASED ON HAVING TO PULL THROUGH THIS TORTUOUS "Z".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057971 ZOOM¿ 88 LARGE DISTAL PLATFORM GUIDE CATHETER QJP IMPERATIVE CARE. INC ICAC088095 00812212030337

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Required Intervention CAROTID STENT| GUIDEWIRE| SHORT SHEATH| SNARE