BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDIGUARD IAB CATHETER

    MDR report key: 57482 · Received October 3, 1996

    Report

    Report Number
    1222008-1996-00030
    Event Type
    Malfunction
    Date Received
    October 3, 1996
    Date of Event
    September 2, 1996
    Report Date
    October 3, 1996
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON INSERTED IN CCU TO STABLE PT. SHE WAS A NON SURGICAL PT. 9 1/2 HRS AFTER INSERTION PERF. WAS CALLED DUE TO BLOOD IN THE TUBING. BALLOON WAS REMOVED AND SECOND BALLOON WAS INSERTED PT HAD A STROKE BUT IS NOW DISCHARGED FROM HOSPITAL AND IS CURRENTLY IN RE-HAB. BALLOON WAS IN USE TO STABILIZE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDIGUARD IAB CATHETER Implant INTRA-AORTIC BALLOON DSP BARD VASCULAR SYSTEM NA 507648

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR BARD TRANSACT