BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 108576 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00748
    Event Type
    Injury
    Date Received
    July 25, 1997
    Report Date
    June 30, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF TWO CASES OF ENTRAPPED IAB'S INVOLVING TWO 48 YEAR-OLD MEN OCCURRING FROM 1971 THROUGH 1991. THE INFO WAS REPORTED IN THE 1993 ISSUE OF "THE ANINALS OF THORACIC SURGERY"; VOLUME 56: PAGES 368-70. THE IABS IN QUESTION WERE NOT RETURNED TO DATASCOPE. THIS IS LITERATURE REFERENCE ONLY. NO FURTHER INFO IS AVAILABLE. (EVENT COMPLICATIONS: THE IAB WAS ENTRAPPED/SURGICALLY REMOVED.) (PT'S CURRENT STATUS: UNKNOWN.)

    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 48 YR Required Intervention