BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANSFIELD BOSTON SCIENTIFIC CORP.

    MDR report key: 242053 · Received September 22, 1999

    Report

    Report Number
    MW1017226
    Event Type
    Malfunction
    Date Received
    September 22, 1999
    Date of Event
    September 17, 1999
    Report Date
    September 22, 1999
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VALVULOPLASTY BALLOON INFLATED AT 1 ATM, BALLOON RUPTURED ON FIRST INFLATION. PRODUCT LABELED RATED TO 2.7 ATM. PRODUCT RETURNED TO MFR 9/22/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANSFIELD BOSTON SCIENTIFIC CORP. BALLOON DIALATION CATHETER MAD BOSTON SCIENTIFIC CORP. VACAS/25 3/10/100 596219

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other