BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE

    MDR report key: 109465 · Received July 29, 1997

    Report

    Report Number
    MW1011788
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    July 19, 1997
    Report Date
    July 29, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    BLOOD NOTED IN EXTRACORPORAL TUBING OF INTRA-AORTIC BALLOON INDICATIVE OF A PERFORATION. ATTEMPTS TO REMOVE BALLOON WERE UNSUCCESSFUL. BALLOON WAS REMOVED SURGICALLY BY A THORACIC SURGEON. VISUAL INSPECTION REVEALED POWDERED CLOTS INSIDE BALLOON. A PORTION OF THE BALLOON CATHETER WAS SAVED FOR INVESTIGATIVE PURPOSES. THE BALLOON WILL BE RETAINED BY THE HOSPITAL AND IF RELEASED BY RISK MGMT WILL BE SENT TO DATASCOPE CORPORATION FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 9.5 FR. 34CC SHEATHLESS *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention