BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL

    MDR report key: 3844809 · Received May 16, 2014

    Report

    Report Number
    2529252-2014-00003
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K934901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS CASE IS NOT EXPECTED TO BE RETURNED. NO PHOTOGRAPHS WERE TAKEN OF THE DEVICE. THE DEVICE HISTORY WAS NOT ABLE TO BE REVIEWED. THE LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY. MERIT IS UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME DUE TO LACK OF AVAILABLE INFORMATION AND NO COMPLAINT SAMPLE BEING RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT "DURING THE IMPLANT PROCEDURE, THE PATIENT SUFFERED SUDDEN CARDIAC ARREST. THE SUBCLAVIAN VEIN HAD BEEN PUNCTURED, AND WHEN PASSING DOWN THE GUIDE WIRE, THE PATIENT DEVELOPED MYOCARDIAL STANDSTILL. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, BUT THE PATIENT DID NOT SURVIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293641 TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL INTRODUCER, CATHETER DYB MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death