BEUDAMED
    FDA Adverse Event Summary report: N

    WILLIAMS RIGHT 5 FRENCH ANGIOGRAPHIC CATHETER

    MDR report key: 3052839 · Received April 5, 2013

    Report

    Report Number
    MW5029701
    Date Received
    April 5, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION, 5 FRENCH WILLIAMS RIGHT (WR) ANGIOGRAPHIC CATHETER BROKE IN HALF WHILE ATTEMPTING TO GAIN ACCESS TO THE OSTIUM OF THE RIGHT CORONARY ARTERY. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE REMAINING PIECE. VASCULAR CONSULT OBTAINED AND RECOMMENDATION MADE TO TRANSFER PT TO TERTIARY CARE. F/U WITH PHYSICIAN AT (B)(6) 2013; PT IS DOING WELL. SHE HAD THE REMAINING CATHETER REMOVED AND HAD STENTING AS PLANNED. SHE IS EXPECTED TO GO HOME TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141736 WILLIAMS RIGHT 5 FRENCH ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO BOSTON SCIENTIFIC 50705029

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R