BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 189125 · Received September 23, 1998

    Report

    Report Number
    2248146-1998-01079
    Event Type
    Malfunction
    Date Received
    September 23, 1998
    Date of Event
    September 11, 1998
    Report Date
    September 16, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01153) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/2/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS NOTED IN THE BALLOON TUBING. PUMPING WAS STOPPED AND THE BALLOON WAS CLAMPED. THE DOCTOR WAS CALLED AND THE IAB WAS REMOVED WITHIN 30 MINUTES OF THE LEAK. ANOTHER BALLOON WAS INSERTED INTO THE PATIENT. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 9/11/98. IT WAS REPORTED THAT THE PATIENT EXPIRED ON 9/16/98. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/16/98; NONE - RPT'D 10/2/98. [PATIENT'S CURRENT STATUS]: EXPIRED 9/16-RPT'D 10/2.

    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 06/13/99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR