BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR RX PTCA BALLOON CATHETER

    MDR report key: 1101945 · Received August 6, 2008

    Report

    Report Number
    9616099-2008-01929
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, AS OF TO DATE THE EVAL HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE THE BALLOON ON THE 2.5X15MM DURA STAR BALLOON CATHETER RUPTURED. THE PROBLEM OCCURRED DURING THE FIRST INFLATION ATTEMPT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 13404844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK