BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 117128 · Received August 30, 1997

    Report

    Report Number
    2248146-1997-00914
    Event Type
    Malfunction
    Date Received
    August 30, 1997
    Date of Event
    July 16, 1997
    Report Date
    August 8, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A 40 CC IAB INSERTED INTO A CUTDOWN OVER THE RIGHT FEMORAL ARTERY ON 7/11/97. ON 7/16/97, BLOOD WAS NOTED IN THE CATHETER. THE PT WAS TAKEN TO SURGERY THE SAME DAY FOR THE REMOVAL OF THE IAB. A SECOND IAB WAS INSERTED. (DATASCOPE WAS NOTIFIED OF THIS EVENT ON 8/8/97 VIA THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 29003-97-0004) ON 8/14/97, DATASCOPE WAS NOTIFIED THAT THE IAB WOULD NOT BE RELEASED TO DATASCOPE. AN EVALUATION WOULD BE AVAILABLE ON SITE ONLY. (EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 8/8/97.) (PT'S CURRENT STATUS: UNK - RPT'D 8/8/97.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0306 02/22/99

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR