BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM

    MDR report key: 2103368 · Received May 17, 2011

    Report

    Report Number
    3005188751-2011-00054
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - ONE 8.5F BRAIDED SWARTZ INTRODUCER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO THE WHITE HANDLE ON THE STOPCOCK AT THE STOPPER, WHICH HAD BEEN OVER ROTATED CAUSING THE HANDLE TO GO BEYOND THE STOP POINT AND COMPLETELY ROTATE WHEN TURNED. A SCREW ON SYRINGE WAS FILLED WITH GREEN DYE AND WAS ATTACHED TO ONE PORT OF THE STOPCOCK AND THE CATHETER SHAFT WAS CLAMPED OFF. THE GREEN DYE WAS PUSHED THROUGH THE STOPCOCK WITH THE HANDLE BEING ROTATED; NO LEAK WAS OBSERVED BETWEEN THE HANDLE WALL AND THE STOPCOCK. IF THE STOPCOCK WAS OVER ROTATED AND CAME IN CONTACT WITH THE UNUSED PORT, THEN GREEN DYE WOULD EXIT THROUGH THE UNUSED STOPCOCK PORT. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT THE LUER HUB ON THE STOPCOCK OF THE SWARTZ INTRODUCER WOULD NOT LOCK ONTO THE LUER TIP OF THE NON SJM INFUSION TUBING. THE PHYSICIAN NOTED THAT THE CONNECTION WAS LOOSE AS HE WAS ATTACHING THE PRESSURE TUBING WHILE THE INTRODUCER SHEATH WAS IN THE PATIENT. THE TUBING SET WAS EXCHANGED AND THE SAME ISSUE WAS NOTED. THE INTRODUCER SHEATH WAS THEN EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT. DEVICE INVESTIGATION REVEALED DAMAGE TO THE STOPCOCK CAUSED BY OVER-ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM SWARTZ, 8.5F, INTRO, SL0 DYB ST. JUDE MEDICAL, AF DIVISION 407451 3310506

    Patients

    Seq Age Sex Outcome Treatment
    1