BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATASCOPE

    MDR report key: 111820 · Received August 5, 1997

    Report

    Report Number
    111820
    Event Type
    Other
    Date Received
    August 5, 1997
    Date of Event
    July 16, 1997
    Report Date
    July 28, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A DATASCOPE #40 INTRA-AORTIC BALLOON CATHETER INSERTED INTO A CUTDOWN OVER THE RIGHT COMMON FEMORAL ARTERY ON 7/11/97. ON 7/16/97 IT WAS NOTED THAT THERE WAS BLOOD IN THE CATHETER SHEATH INDICATING THAT IT HAD RUPTURED. PT WAS TAKEN TO SURGERY THE SAME DAY FOR THE REMOVAL OF THE OLD CATHETER AND THE PLACEMENT OF A DATASCOPE #50 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE Implant INTRA AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-262-01 J1488632

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other