BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLOON CATHETER

    MDR report key: 1082636 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01238
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    April 8, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOD
    PMA / PMN Number
    K841941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVAL. BOTH PROXIMAL AND DISTAL BALLOON BONDS WERE FOUND TO BE CONTINUOUS, INTACT AND WITHIN SPECIFICATION. ON INSPECTION OF THE BALLOON, THE BALLOON WAS FOUND TO BE BURST/ RUPTURED IN THE MID-SECTION, ABOVE THE SKIVE HOLE. THERE WERE NO OTHER DEFECTS FOUND THAT COULD POTENTIALLY CAUSED THE BALLOON BURST. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE BALLOON BURST CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO CONTACT WITH A SHARP EXTERIOR SOURCE, SUCH AS SHARP CALCULI OR DAMAGE DURING INSERTION THROUGH THE SCOPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE STONE WAS LOCATED IN THE URETEROPELVIC JUNCTION (UPJ). THE OB OCCLUSIVE BALLOON CATHETER WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO INFLATE THE BALLOON, THE BALLOON FAILED TO INFLATE. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE". DEVICE ANALYSIS REVEALED A BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON CATHETER KOD BOSTON SCIENTIFIC M0062201020 11202584

    Patients

    Seq Age Sex Outcome Treatment
    1