BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN VENOGRAM BALLOON CATHETER

    MDR report key: 6007906 · Received October 6, 2016

    Report

    Report Number
    2182208-2016-02392
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYG
    PMA / PMN Number
    K012225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND AFTER THE PHYSICIAN CLOSED THE INCISION OF THE POCKET, TWO LONG THREADS OF DEBRIS WERE PULLED FROM THE OPERATIVE FIELD. IT WAS SUSPECTED, BUT UNCONFIRMED, THAT THESE WERE PART OF THE SHEATHS USED DURING THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655549 ATTAIN VENOGRAM BALLOON CATHETER CATHETER, FLOW DIRECTED DYG MEDTRONIC, INC. 6215 61390991

    Patients

    Seq Age Sex Outcome Treatment
    1