BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM

    MDR report key: 2180951 · Received July 7, 2011

    Report

    Report Number
    3005188751-2011-00115
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR - VISUAL INSPECTION REVEALED THE WAVE SPRING HAD DETACHED FROM THE HANDLE, CAUSING THE HANDLE VALVE ASSEMBLY TO COME OFF FROM THE NEEDLE. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THE WAVESPRING DETACHMENTS. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AFTER THE SECOND TRANSEPTAL PUNCTURE, THE PHYSICIAN NOTED THE WAVESPRING DETACHED, CAUSING THE HANDLE/VALVE ASSEMBLY TO SEPARATE FROM THE PROXIMAL END OF THE NEEDLE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM BRK-1, XS NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION G407209 3377886

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR