BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5FR. 40CC. IAB

    MDR report key: 49418 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00092
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Report Date
    September 4, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE NEW SHEATHLESS GUARD ON THE CATHETER TAKES UP TOO MUCH ROOM THAT MAKES IT VERY DIFFICULT TO ADVANCE THE CATHETER INTO THE CORRECT PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5FR. 40CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684000321 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN