BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAIM-TURI CATHETER

    MDR report key: 36754 · Received July 10, 1996

    Report

    Report Number
    36754
    Event Type
    Injury
    Date Received
    July 10, 1996
    Date of Event
    May 3, 1996
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED COMPLETE HEART BLOCK DURING PTCA PROCEDURE FOR RIGHT INFERIOR BLOCKAGE. DURING PLACEMENT OF THE CATHETER, THE RIGHT VENTRICULAR WALL WAS PERFORATED, RESULTING IN CARDIAC TAMPONADE. TAMPONADE WAS TREATED EMERGENTLY WITH MEDIAN STERNOTOMY TO REMOVE THE CATHETER AND REPAIR THE VENTRICULAR WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIM-TURI CATHETER TEMPORARY INTERNAL CARDIAC PACING CATHETER DYG USCI DIV. C.R. BARD, INC. 7F 110 CM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention