BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E BALLOON DILATATION CATHETER

    MDR report key: 1213737 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05440
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THERE WAS DIFFICULTY REMOVING THE BALLOON THROUGH THE SCOPE. THE PHYSICIAN USED THE CRE WIRE-GUIDED BALLOON TO DILATE THE ESOPHAGUS SUCCESSFULLY. WHEN THE BALLOON WAS BEING REMOVED IT WAS STUCK AT THE DISTAL END OF THE SCOPE. THE DEVICE WAS REMOVED BY REMOVING THE SCOPE FROM THE PATIENT, PULLING ON THE BALLOON AND CUTTING THE BALLOON CATHETER OFF USING A WIRE CUTTER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE "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 CORK LTD. M00558380 0011939652

    Patients

    Seq Age Sex Outcome Treatment
    1 FUJI DIAGNOSTIC UPPERSCOPE