BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1081514 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01291
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR. REPORT #3005099803-2008-01290. IT WAS REPORTED THAT DURING A GASTRO-ESOPHAGEAL DILATATION (EGD) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, TWO BALLOON RUPTURES OCCURRED. THE LESION WAS LOCATED IN THE PYLORUS. THE CRE 15MM X 18MM BALLOON DILATATION CATHETER WAS ADVANCED THROUGH THE ENDOSCOPE, HOWEVER, THE BALLOON "POPPED AGAINST THE ELEVATOR OF THE ERCP SCOPE". THE DEVICE WAS REMOVED AND A SECOND CRE 15MM X 18MM BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE, HOWEVER, THIS BALLOON "ALSO POPPED AGAINST THE ELEVATOR OF THE ENDOSCOPE". THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558370

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR