BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON

    MDR report key: 10565 · Received December 20, 1993

    Report

    Report Number
    MW1000142
    Event Type
    Injury
    Date Received
    December 20, 1993
    Date of Event
    December 4, 1993
    Report Date
    December 10, 1993
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    AN INTRA-AORTIC BALLOON WAS INSERTED UNDER FLUOROSCOPY. BLOOD LOSS WAS NOTED AT THE JUNCTURE BETWEEN THE CUFF ADAPTER AND THE HUB OF THE SHEATH WHICH COULD NOT BE REMEDIED BY SUTURING. THE BALLOON WAS IMMEDIATELY DISCONTINUED, AND ANOTHER BALLOON WAS INSERTED SHEATHLESS. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON KONTRON INSTRUMENTS, INC. 9.0 FR 40 CC DL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 * Required Intervention