BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE

    MDR report key: 213030 · Received March 4, 1999

    Report

    Report Number
    MW1015825
    Event Type
    Malfunction
    Date Received
    March 4, 1999
    Date of Event
    December 15, 1998
    Report Date
    December 16, 1998
    Manufacturer
    DATASCOPE CORP. CARDIAC ASSIST
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MFR. ON 04/09/1999: THE IAB WAS THE RESULT OF A BREAK OF THE INNER LUMEN. IT IS POSSIBLE THAT THE IAB WAS RESTRAINED WITHIN THE AORTA DURING IABP. IT IS ALSO POSSIBLE THAT THE INITIAL KINK IN THE INNER LUMEN WAS MADE DURING IAB INSERTION AND THAT THE IABP CONTINUED TO CYCLICALLY STRESS THE INNER LUMEN AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE Implant 40CC IAB CATHETER DSP DATASCOPE CORP. CARDIAC ASSIST J1657853 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other