BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT SL 8.5 FR. 40 CC. IAB

    MDR report key: 185198 · Received August 27, 1998

    Report

    Report Number
    2248146-1998-00984
    Event Type
    Death
    Date Received
    August 27, 1998
    Date of Event
    August 16, 1998
    Report Date
    August 20, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01046) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 9/8/98, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER-FACILITY; UF/DIST REPORT NUMBER: NONE. THE FOLLOWING INFORMATION WAS REPORTED: THE IAB WAS INSERTED INTO THE PATIENT ON 8/14/98. ON 8/16/98 THE IAB RUPTURED. A CODE BLUE WAS CALLED AND THE PATIENT WENT ON TO EXPIRE ON 8/16/98. ON 9/14/98, THE FOLLOWING INFORMATION WAS REPORTED TO DATASCOPE: THE DOCTOR HAD DIFFICULTY INSERTING EVEN THE GUIDEWIRE. THE PATIENT WENT INTO V-TACH, V-FIB, ASYSTOLE AND WENT ON TO EXPIRE. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/20/98; EXPIRED-REPORTED 9/8/98, 9/14/98. [PATIENT'S CURRENT STATUS]: EXPIRED - RPT'D 9/8/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT SL 8.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0183 10/09/98

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death