BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA-THIN ANGIOPLASTY BALLOON

    MDR report key: 11352 · Received February 7, 1994

    Report

    Report Number
    MW1000656
    Event Type
    Other
    Date Received
    February 7, 1994
    Date of Event
    January 11, 1994
    Report Date
    January 21, 1994
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANGIOPLASTY BALLOON RUPTURE OCCURRED WITH MILD TO MODERATE INFLATION PRESSURE, WHILE PERFORMING ANGIOPLASTY OF SUPERFICIAL FEMORAL ARTERY STENOSIS. A REPEAT ANGIOPLASTY WAS IMMEDIATELY PERFORMED WITH A NEW BALLOON WITH GOOD FINAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN ANGIOPLASTY BALLOON LIT BOSTON SCIENTIFIC CORP. ULTRA THIN 5/2/5/75 133318

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other