BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 526081 · Received February 19, 2004

    Report

    Report Number
    1062385-2004-00004
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    January 28, 2004
    Report Date
    February 19, 2004
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER HAD DIFFICULTY ADVANCING THE CATHETER AND REMOVED IT, USED A CUTTING BALLOON TO DILATE AGAIN. THE CBA WAS DAMAGED. THE CATHETER WAS REINSERTED WHICH WAS DIFFICULT BUT SUCCESSFUL. AFTER SUCCESSFUL VBT PROCEDURE, WHILE PULLING BACK THE CATHETER THE CATHETER STUCK ON THE GUIDEWIRE AND THE USER PULLED BOTH OUT. USER WAS NOT SURE WHICH DEVICE CAUSED A PROXIMAL DISSECTION WHICH REMAINED UNTREATED AS IT WAS NOT SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. NA 657077

    Patients

    Seq Age Sex Outcome Treatment
    1 *