BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE ESOPHAGEAL/PHYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER

    MDR report key: 1213744 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05435
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 A GASTROSCOPY PROCEDURE, THE BALLOON SPLIT. A CRE WG 15-18MM/240CM/5.5 F/G HAD BEEN ADVANCED THROUGH THE SCOPE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE AND RESISTANCE WAS ENCOUNTERED. THE BALLOON CATHETER WAS REMOVED FROM THE SCOPE AND IT WAS NOTICED THAT THE BALLOON APPEARED TO BE "SPLIT". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE ESOPHAGEAL/PHYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558490 11483651

    Patients

    Seq Age Sex Outcome Treatment
    1