BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATATION CATHETER, BALLOON

    MDR report key: 2003992 · Received March 1, 2011

    Report

    Report Number
    3005099803-2011-00524
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LJE
    PMA / PMN Number
    K952968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON DILATATION CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR A STONE WITHIN THE RIGHT KIDNEY. A SENSOR GUIDEWIRE AND AN AMPLATZ GUIDEWIRE WERE PLACED WITHIN THE PATIENT'S KIDNEY. THE BALLOON CATHETER WAS INSERTED APPROXIMATELY 5-6 CM THROUGH THE PATIENT'S BACK WHEN THE CATHETER BENT AND COULD NOT BE INSERTED ANY FURTHER. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT. A SECOND NEPHROMAX NEPHROSTOMY BALLOON DILATATION CATHETER WAS USED WITH THE SAME GUIDEWIRES TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILATATION CATHETER, BALLOON CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC - GALWAY M0062101180 11645900

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR