BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188080 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01019
    Event Type
    Injury
    Date Received
    September 16, 1998
    Date of Event
    June 28, 1998
    Report Date
    August 24, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PATIENT ON 06/26/1998 AT 11:45 A.M. AND REMOVED ON 06/28/1998 AT 10:00 P.M. THE IAB DID NOT MALFUNCTION. THE PATIENT HAD MAJOR ISCHEMIA AND REMOVAL OF THE IAB WAS REQUIRED. THE PATIENT WENT ON TO EXPIRE ON 06/28/1998 AT 10:00 P.M. THE CONTACT STATED THAT THE PATIENT'S DEATH WAS NOT A DIRECT CONSEQUENCE OF THE IAB OR IAB THERAPY. THE IAB WAS NOT RETURNED TO DATASCOPE. (EVENT COMPLICATIONS: MAJOR ISCHEMIA/REMOVAL REQUIRED - REPORTED 08/24/1998.) (PT'S CURRENT STATUS: EXPIRED - REPORTED 08/24/1998.)

    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. 0684-00-0269 03/03/00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention