BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1213745 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05423
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, THE SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATATION PROCEDURE, DEFLATION AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE ESOPHAGUS. THE CRE 18MM X 20MM BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED AN UNSPECIFIED NUMBER OF TIMES TO UNSPECIFIED ATMS. UPON ATTEMPTING TO DEFLATE THE BALLOON, THE HANDLE OF THE ALLIANCE II INFLATION DEVICE WAS PLACED INTO THE REVERSE SETTING AND PUMPED UNTIL THE SYRINGE REACHED ITS END POINT, HOWEVER, THIS DID NOT PROVIDE ADEQUATE DEFLATION OF THE BALLOON AND THE BALLOON WAS UNABLE TO BE REMOVED. IT WAS NOT KNOWN HOW THE BALLOON WAS REMOVED. NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558380

    Patients

    Seq Age Sex Outcome Treatment
    1