BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIFLEX II ACHALASIA BALLOON DILATOR

    MDR report key: 1182299 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04945
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A RIGIFLEX II ACHALASIA BALLOON DILATOR DEVICE WAS USED IN THE PT'S CARDIA. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS NOT ABLE TO PRESSURIZE THE BALLOON TO 20PSI PRESSURE, IT WAS REPORTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX II ACHALASIA BALLOON DILATOR KNQ BOSTON SCIENTIFIC CORPORATION M00554500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK