BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR RX PTCA BALLOON CATHETER

    MDR report key: 1181503 · Received September 25, 2008

    Report

    Report Number
    9616099-2008-02346
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE THE PRODUCT 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 TOOK THE 3.5X20 MM DURASTAR BALLOON INTO A STENTED REGION OF ARTERY AND INFLATED THE BALLOON TO 14 ATMOSPHERES, 3 TIMES. AFTER THE THIRD INFLATION, THE PHYSICIAN TRIED TO WITHDRAW THE BALLOON BACK INTO THE CATHETER AND WAS UNABLE TO DO SO. AFTER REPEATED ATTEMPTS, THE PHYSICIAN RE-INFLATED THE BALLOON AND WAS THEN ABLE TO WITHDRAW THE BALLOON INTO THE CATHETER. THERE WAS NO REPORT OF INJURY.

    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 13383223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK