BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 55791 · Received December 11, 1996

    Report

    Report Number
    2248146-1996-00361
    Event Type
    Injury
    Date Received
    December 11, 1996
    Date of Event
    June 11, 1995
    Report Date
    November 11, 1996
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CO ON 11/11/96 VIA THE VOLUNTARY MEDWATCH FORM FROM THE FDA (MDR ACCESS NUMBER: 4001666). THE SYSTEM BEGAN ALARMING AND FRANK BLOOD WAS NOTED IN THE CONNECTING TUBING FROM THE BALLOON TO THE PUMP. AS A RESULT OF THE EVENT, THE PT BECAME UNSTABLE WITH ECC CHANGES. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. THE PT'S CONDITION IMPROVED AND REMAINED STABLE. EVENT COMPLICATIONS: THE PT BECAME UNSTABLE WITH ECC CHANGES - RPT'D 11/11/96. PT'S CURRENT STATUS: IMPROVED - RPT'D 11/11/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening