BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1051674 · Received May 19, 2008

    Report

    Report Number
    3005099803-2008-00503
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED, BUT THE DEVICE EVALUATION IS NOT COMPLETE; THEREFORE THE CAUSE OF THE REPORTED BALLOON RUPTURE IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR THIS LOT. THE APRIL 2008 15-MONTH CRE BALLOONS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A CRE BALLOON DILATATION CATHETER DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE "THE BALLOON RUPTURED DURING INFLATION." THE PROCEDURE WAS COMPLETED WITH A SECOND CRE BALLOON DILATATION CATHETER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER KOG BOSTON SCIENTIFIC CORK LTD. M00558500 11377169

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK