BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE ESOPHAGEAL/COLONIC WIREGUIDED BALLOON DILATATION CATHETER

    MDR report key: 1193217 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05096
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ESOPHAGUS. THE CRE WG 18-20MM/240/5.5 F/G ESOPHAGEAL/COLONIC WIREGUIDED BALLOON DILATATION CATHETER WAS INFLATED TO 6 ATM'S WHEN IT BURST. THE PROCEDURE WAS UNABLE TO BE COMPLETED. FLUOROSCOPY CONFIRMED THAT NO PORTION OF THE BALLOON REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE ESOPHAGEAL/COLONIC WIREGUIDED BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK LTD. M00558500 11806943

    Patients

    Seq Age Sex Outcome Treatment
    1