BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40MM BETA-CATH DELIVERY CATHETER

    MDR report key: 436346 · Received January 2, 2003

    Report

    Report Number
    1062385-2002-00043
    Event Type
    Malfunction
    Date Received
    January 2, 2003
    Date of Event
    December 13, 2002
    Report Date
    January 2, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT THE 40MM BETA-CATH DELIVE3RY CATHETER WAS PUNCTURED. THE SITE REPORTED THAT THE CATHETER WAS PUNCTURED POSSIBLY FROM THE STENT. NO PT ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE 40MM BETA-CATH DELIVERY CATHETER WAS PUNCTURED. THE SITE REPORTED THAT THE CATHETER WAS PUNCTURED POSSIBLY FROM THE STENT. NO PT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 40MM BETA-CATH DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. 510609-040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *