BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLOON CATHETER

    MDR report key: 1171323 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04637
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOD
    PMA / PMN Number
    K841941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS AND FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "PCNL" PROCEDURE THE OCCLUSION BALLOON LEAKED. THE TARGET LESION WAS IN THE URETEROPELVIC JUNCTION (UPJ). AT AN UNSPECIFIED TIME DURING THE PROCEDURE, AN OCCLUSION BALLOON LEAKED. THE PROCEDURE WAS DELAYED 25 MINUTES WHILE ANOTHER OF THE SAME DEVICE COULD BE OBTAINED FROM ANOTHER FACILITY. THE SECOND BALLOON WOULD NOT STAY INFLATED DESPITE NO VISIBLE SIGNS OF LEAKAGE. THE PROCEDURE WAS COMPLETED WITH A 3RD OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON CATHETER KOD BOSTON SCIENTIFIC M0062201090

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR