BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FORCE BALLOON DILATION CATHETER

    MDR report key: 4102673 · Received August 28, 2014

    Report

    Report Number
    1018233-2014-00223
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 6, 2014
    Manufacturer
    C.R. BARD, INC.C.R. BARD, INC (COVINGTON)
    Product Code
    EZN
    PMA / PMN Number
    K050875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SHAFT RUPTURED WHILE INFLATING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523901 X-FORCE BALLOON DILATION CATHETER EZN C.R. BARD, INC.C.R. BARD, INC (COVINGTON) NA BMXJE003

    Patients

    Seq Age Sex Outcome Treatment
    1