BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE-INTRA AORTA BALLOON PUMP

    MDR report key: 15117 · Received January 4, 1994

    Report

    Report Number
    15117
    Event Type
    Injury
    Date Received
    January 4, 1994
    Date of Event
    August 13, 1993
    Report Date
    August 31, 1993
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IABP CATHETER PULLED OUT BY SURGEON AFTER "CLOTTED OFF" PORTION OF CATHETER TORE OFF. REMOVED PIECE WAS 26CM IN LENGTH BY 1.5CM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE-INTRA AORTA BALLOON PUMP Implant INTRA AORTA BALLOON PUMP DSP DATASCOPE CORPORATION DATASCOPE 9.5 FR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R