BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAREXS 8F 110CM (STRAUB MEDICAL)

    MDR report key: 10240140 · Received July 7, 2020

    Report

    Report Number
    3008439199-2020-00016
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 16, 2020
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810391
    PMA / PMN Number
    K172315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY REPORT ATTACHED IN GERMAN WAS TRANSLATED TO ENGLISH.

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE WILL BE NOT RETURNED. PHOTOS OR VIDEOS OF PROCEDURE WERE REQUESTED.

    Description of Event or Problem · 1

    AFTER TREATMENT OF CIA AND CFA LEFT THE ROTAREX HEAD BREAKS OF UNEXPECTLY WITHOUT WARNING (LIKE DROP OF ROTATIONS OR NOISE) AND LIES IN AN UNPERFUSED SMALL SIDE BRANCH OF THE CFA. THE ROTAREX HEAD CAN BE CAUGHT BUT NOT PASSED THROUGH THE EXISTING STENT CFA. THE ROTAREX HEAD IS THEREFORE PLACED PERMANENTLY IN THE SMALL UNPERFUSED SIDE BRANCH OF THE CFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702391 ROTAREXS 8F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER MCW STRAUB MEDICAL AG ROTAREX®S 8F X 110CM 190978 07640142810391

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S