BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEMPORARY PACING ELECTRODE CATHETER

    MDR report key: 6053506 · Received October 21, 2016

    Report

    Report Number
    MW5065556
    Event Type
    Other
    Date Received
    October 21, 2016
    Date of Event
    October 15, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BARD MEDICAL
    Product Code
    LDF
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    NURSE CONNECTED SYRINGE FILLED WITH SALINE TO BALLOON PORT ON PACEMAKER TO FLUSH SALINE THROUGH CAUSING RUPTURE OF LEFT VENTRICLE AND NEED FOR EMERGENT CARDIAC REPAIR. RECOMMENDATION THAT MFR CONSIDERS HAVING CONNECTOR WHERE BALLOON IS CONNECTED TO NOT BE COMPATIBLE WITH REGULAR SYRINGE, OTHER VISUAL DUE SUCH AS TAG STATING DO NOT USE FOR FLUSHING, OR RED COLOR TO HELP USER KNOW THAT THE PORT SHOULD NOT BE USED FOR FLUSHING. PT EXPIRED 6 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697422 TEMPORARY PACING ELECTRODE CATHETER TEMPORARY PACING ELECTRODE CATHETER LDF BARD MEDICAL 006173P

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other