BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1222663 · Received November 3, 2008

    Report

    Report Number
    1222663
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING CUTTING BALLOON ANGIOPLASTY OF FEM-POP ANASTOMOTIC STENOSIS. THE FIRST BALLOON USED DID NOT INFLATE. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, BALLOON DILATATION LIT BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION * EH5345

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR