BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWAY INTRODUCER KIT 7F, .038, 14CM SHEATH

    MDR report key: 3812498 · Received May 5, 2014

    Report

    Report Number
    3005188751-2014-00071
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DQX
    PMA / PMN Number
    K791129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PACEMAKER IMPLANT PROCEDURE USING A PEEL AWAY INTRODUCER, A PORTION OF THE INTRODUCER DETACHED AND REMAINED IN THE PATIENT'S VASCULATURE. AFTER IMPLANTATION OF THE RIGHT VENTRICULAR PACING LEAD, A 7CM PORTION OF THE PEEL AWAY INTRODUCER BECAME DETACHED AND REMAINED IN THE VASCULATURE. A SNARE DEVICE WAS USED TO REMOVE THE INTRODUCER FRAGMENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268025 PEEL-AWAY INTRODUCER KIT 7F, .038, 14CM SHEATH DQX ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 405108 4400763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSURITY PACEMAKER, (PM2240/2932806)| OPTISENSE PACING LEAD, (199-52/CWK054688)| TENDRIL STS PACING LEAD, (2088TC-58/(B)(4))| TENDRIL STS PACING LEAD, (2088TC-58/(B)(4))