BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 507091 · Received January 5, 2004

    Report

    Report Number
    MW1030746
    Event Type
    Malfunction
    Date Received
    January 5, 2004
    Date of Event
    December 23, 2003
    Report Date
    December 24, 2003
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON INSERTING STENT, DR. COULD NOT ADVANCE STENT PAST PROXIMAL PORTION OF LESION AND DECIDED TO RETRACT STENT TO REPLACE IT WITH A SMALLER SIZE STENT. WHEN STENT WAS PULLED BACK INTO GUIDE CATHETER THE PROXIMAL PORTION OF STENT BECAME CAUGHT ON SUPERIOR ASPECT OF CATHETER TIP. THE STENT BEGAN TO FRAY AND WHOLE SYSTEM WAS REMOVED AT SAME TIME AND PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC IC STENT EXPRESS 2 MAF BOSTON SCIENTIFIC EXPRESS 2 STENT 6021367

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other