BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 180818 · Received August 1, 1998

    Report

    Report Number
    180818
    Event Type
    Malfunction
    Date Received
    August 1, 1998
    Date of Event
    March 12, 1998
    Report Date
    July 6, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/6/98, DATASCOPE REC'D THE MEDWATCH FORM FROM THE USER/FACILITY; UF/DIST REPORT NUMBER 070022-1998-0003 AND THE FOLLOWING INFO WAS REPORTED: A SMALL AMOUNT OF BLOOD WAS NOTED IN THE BALLOON TUBING. THE "BLOOD LOSS" ALARM SOUNDED FROM THE PUMP. BALLOON REMOVAL WAS DIFFICULT TO ACHIEVE. THE PT WAS NOTED BY THE ATTENDING CT SURGEON NOT TO HAVE SIGNIFICANT CALCIUM ON THE AORTA. THE PT WAS THEN CLOSELY OBSERVED FOR SIGNS OF FEMORAL ARTERY INJURY. (EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 7/6/98.) (PT'S CURRENT STATUS: UNK - REPORTED 7/6/98)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 02/20/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN