BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLOON DILATATION CATHETER

    MDR report key: 922239 · Received October 3, 2007

    Report

    Report Number
    6000132-2007-00010
    Event Type
    Malfunction
    Date Received
    October 3, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KOD
    PMA / PMN Number
    K841941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A DEVICE HISTORY RECORD REVIEW, PRODUCT EVALUATION, AND COMPLAINT TREND ANALYSIS ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT AN OCCLUSION BALLOON DILATATION CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE THAT OCCURRED IN 2007. ACCORDING TO THE COMPLAINANT, UPON INFLATION OF THE BALLOON CATHETER TO THE RECOMMENDED PRESSURE, THE BALLOON BURST WHILE INSIDE THE PATIENT'S URETHRA. FOLLOW UP INFORMATION INDICATED THAT THE ENTIRE DEVICE WAS RETRIEVED WHEN THEY PULLED THE CATHETER OUT; ALL PIECES OF THE BALLOON WERE STILL ATTACHED COMPLETELY. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT. ACCORDING THE COMPLAINANT, THIS EVENT OCCURRED TWICE WITH TWO DIFFERENT DEVICES ON THE SAME PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD DEVICE. PLEASE REFER TO MEDWATCH REPORT#:6000132-2007-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON DILATATION CATHETER KOD BOSTON SCIENTIFIC CORK LTD. M0062201030 8952185

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR