BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATATION CATHETER, BALLOON

    MDR report key: 2222510 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02841
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LJE
    PMA / PMN Number
    K952968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON DILATATION CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN AUGUST 2011. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, WHILE THE BALLOON WAS BEING INFLATED INSIDE THE PATIENT, THE DISTAL TIP OF THE BALLOON CATHETER KINKED. THE LEVEEN INFLATOR INCLUDED WITH THE BALLOON KIT WAS USED FOR INFLATION. THE KINK MADE IT DIFFICULT TO ADVANCE THE ACCESS SHEATH OVER THE BALLOON TO MAINTAIN DILATATION AND THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY PASS THE SHEATH OVER THE BALLOON. NO DEFECTS WERE NOTED TO THE BALLOON CATHETER WHEN IT WAS REMOVED FROM THE PACKAGE. THE BALLOON WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER NEPHROMAX BALLOON AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILATATION CATHETER, BALLOON CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC - GALWAY UNK265

    Patients

    Seq Age Sex Outcome Treatment
    1