BEUDAMED
    FDA Adverse Event Death Summary report: N

    BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER

    MDR report key: 1951829 · Received December 23, 2010

    Report

    Report Number
    1222791-2010-00008
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 1, 2010
    Manufacturer
    C.R. BARD, INC. (BEP)
    Product Code
    LDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED DUE TO A DEATH ASSOCIATED WITH THIS DEVICE. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF AN INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS DEVICE WAS TAKEN OFF THE CODE CART, REMOVED FROM THE PACKAGING, TESTED AND DURING TESTING THE BALLOON WAS NOTED TO BE BROKEN. IT WAS NEVER USED ON THE PT. THE NURSE OBTAINED ANOTHER UNIT FROM THE CATH LAB WHICH WORKED FINE. THE PT WAS STABILIZED AND WENT TO ICU. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2010 RELAYED THAT THE PT EXPIRED SOMETIME FOLLOWING THE TRANSFER TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER LDF C.R. BARD, INC. (BEP) GFTB2933

    Patients

    Seq Age Sex Outcome Treatment
    1 Death