BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS

    MDR report key: 1473265 · Received July 10, 2009

    Report

    Report Number
    3005099803-2009-03271
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Report Date
    June 11, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K971757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F10: THESE CODES WERE SELECTED BY THE MANUFACTURER BASED UPON INFORMATION OBTAINED FROM THE USER FACILITY. D4 & H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE IS UNKNOWN. THE COMPLAINANT INDICATED THAT DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BSC REFERENCE: A00167684 / 1153581.

    Description of Event or Problem · 1

    NOTE: EVENT DATE IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS WAS USED DURING AN FEEDING TUBE REPLACEMENT PROCEDURE ON A (B) (6) FEMALE PATIENT. ACCORDING TO THE COMPLAINANT, THE BALLOON DEFLATED AND FELL OUT. A NEW ENDOVIVE LOW PROFILE BALLOON WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS KNT BOSTON SCIENTIFIC CORPORATION M00563710

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR