BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEL-AWAY INTRODUCER KIT 6F, .038, 14CM SHEATH

    MDR report key: 2142221 · Received May 26, 2011

    Report

    Report Number
    3005188751-2011-00065
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DTB
    PMA / PMN Number
    K894431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE CAUSE FOR THE REPORTED "CRACKING" OF THE PEEL AWAY INTRODUCER WHEN PEELING COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PEELING THE INTRODUCER OFF A PACEMAKER LEAD, THE INTRODUCER STARTED TO "CRACK" INTO SMALL PIECES. THE PIECES DID NOT ENTER THE PATIENT'S VEIN/BLOODSTREAM, BUT HAD TO BE RETRIEVED FROM THE PACEMAKER POCKET. A SCISSORS AND OTHER TOOLS WERE USED TO PEEL THE INTRODUCER FROM THE LEAD. THERE WERE NO CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL-AWAY INTRODUCER KIT 6F, .038, 14CM SHEATH PEEL-AWAY KIT, 6F, 14CM DTB ST. JUDE MEDICAL, AF DIVISION 405104 3289655

    Patients

    Seq Age Sex Outcome Treatment
    1