BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ BRAIDED TRANSSEPTAL INT., 8F, SL1

    MDR report key: 2093423 · Received April 12, 2011

    Report

    Report Number
    3005188751-2011-00043
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 8F BRAIDED SWARTZ INTRODUCER WAS RECEIVED FOR EVAL. THE INTRODUCER WAS TESTED FOR LEAKS USING PRESSURE AND SUBMERGING THE INTRODUCER IN WATER; A LEAK WAS DETECTED AT THE VALVE. THE HEMOSTASIS CAP WAS REMOVED AND THE 2 PART SEAL WAS EXAMINED, WHICH REVEALED A TEAR IN THE TOP HALF OF THE SEAL SYSTEM, WHICH CAUSED THE LEAK. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEMOSTASIS VALVE DID NOT FUNCTION. ADD'L INFO WAS REQUESTED AND IS NOT AVAILABLE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANSSEPTAL INT., 8F, SL1 SWARTZ INTRO., 8F SL1 DYB ST. JUDE MEDICAL, AF DIVISION NA 3236494

    Patients

    Seq Age Sex Outcome Treatment
    1