BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREXS 6F 110CM (STRAUB MEDICAL)

    MDR report key: 10792735 · Received November 5, 2020

    Report

    Report Number
    3008439199-2020-00056
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 9, 2020
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810575
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY EVALUATION REPORT ATTACHED.

    Additional Manufacturer Narrative · 1

    EVALUATION PROTOCOL NOT COMPLETED YET.

    Description of Event or Problem · 1

    ANASTOMOTIC LESION IN BYPASS GRAFT, PROXIMAL LOCATION. UP AND OVER, NOT A STEEP BIFURCATION. ROTAREX CLUTCHED OUT (NO CALCIFICATION IN GRAFT, PURELY INTIMAL HYPERPLASIA). DEVICE KEPT RUNNING, BUT SAW THE TIP WASN'T SPINNING. BROKEN HELIX CAME OUT OF CATHETER WHEN BEING WITHDRAWN FROM ANSEL SHEATH. 100MM LENGTH BROKE. HI FLEX COOK ANSEL SHEATH. RUN TIME ABOUT 8 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262373 ROTAREXS 6F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER MCW STRAUB MEDICAL AG SET ROTAREX®S 6F X 110CM 200704 07640142810575

    Patients

    Seq Age Sex Outcome Treatment
    1