BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR RX PTCA BALLOON CATHETER

    MDR report key: 1193191 · Received October 7, 2008

    Report

    Report Number
    9616099-2008-02401
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    BALLOON BURST. THE REPORT RECD INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A 3.00 X 10 MM DURA STAR BALLOON CATHETER WAS BEING USED FOR PRE-DILATION OF A HEAVY CALCIFIED LESION; HOWEVER, THE BALLOON BURST AT 20 ATMOSPHERES. THEREFORE, THE PHYSICIAN EXCHANGED THE DEVICE FOR A QUANTUM BALLOON. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETER (LOX) LOX CORDIS DE MEXICO NA 13394856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK