BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR PTCA BALLOON CATHETER

    MDR report key: 1132735 · Received August 22, 2008

    Report

    Report Number
    9616099-2008-02058
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION; HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE PHYSICIAN WAS USING A 2.50 X 15 DURA STAR RX PTCA BALLOON CATHETER TO DILATE A LESION IN THE LEFT ANTERIOR DESCENDING; HOWEVER, THE BALLOON BURST AT 16 ATMOSPHERES. THERE WAS NO PATIENT INJURY REPORTED. THE BURST ON THE BALLOON WAS FURTHER DESCRIBED AS A PIN HOLE; THERE WERE NO OTHER ANOMALIES NOTED ON THE DEVICE. FURTHER INFORMATION INDICATED THAT THE LESION WAS 13 MM LONG, THE LESION WAS DESCRIBED AS A TYPE B, PRESENTING HEAVY CALCIFICATION AND MILD TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA STAR PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 13370000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK