BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD 6F DYNAMIC DECA STERRABLE ELECTRODE CATHETER

    MDR report key: 2844950 · Received October 24, 2012

    Report

    Report Number
    1222791-2012-00007
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    C.R. BARD, INC. (BEP)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE HAS BEEN RECEIVED BY THE MANUFACTURER. THE INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE TIP OF THE STEERABLE CATHETER DID NOT WITHDRAW AS USUAL AT THE END OF THE AF PROCEDURE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO REMOVE THE CATHETER AND UPON WITHDRAWAL THE TIP OF THE CATHETER CAUGHT THE PATIENT'S ENDOCARDIAL TISSUE. THE PHYSICIAN REPORTED NO DIFFICULTY INSERTING THE CATHETER AND REPORTED THAT THE ANATOMY OF THE PATIENT IS NORMAL. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. IT WAS REPORTED AS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 6F DYNAMIC DECA STERRABLE ELECTRODE CATHETER DRF C.R. BARD, INC. (BEP) GFWA2591

    Patients

    Seq Age Sex Outcome Treatment
    1