BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM

    MDR report key: 1910666 · Received November 22, 2010

    Report

    Report Number
    3005188751-2010-00116
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND FUNCTIONAL TESTING OF THE RETURNED INTRODUCER REVEALED NO LEAKS OR BLOCKAGES. ADD'L VISUAL INSPECTION OF THE INTERNAL SEALS REVEALED PROPER ALIGNMENT AND NO DAMAGE NOTED. THE STOPCOCK FUNCTIONED AS DESIGNED; NO LEAKS OR BLOCKAGES WERE DETECTED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(6) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRODUCER WAS INSERTED INTO THE PT WITHOUT DIFFICULTY. THE PHYSICIAN ATTEMPTED TO ASPIRATE BLOOD FROM THE SHEATH VIA THE THREE WAY STOPCOCK BUT WAS UNSUCCESSFUL. THE SHEATH WAS THEN EXCHANGED AND IT WAS POSSIBLE TO ASPIRATE BLOOD FROM THE SHEATH. FOLLOWING THIS, AN ULTRASOUND WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION.

    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 3181805

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other