BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO

    MDR report key: 1781091 · Received July 29, 2010

    Report

    Report Number
    3005188751-2010-00071
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIV
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRODUCER WAS RECEIVED WITH A CONFIRMED LEAK AT THE VALVE. ADDITIONAL TESTING REVEALED THE CAUSE OF THE LEAK WAS A PUNCTURE HOLE IN THE TOP HALF OF THE TWO PART SEAL THAT WAS MADE BY A SHARP OBJECT. THE HOLE WAS CONSISTENT WITH THE SHAPE AND SIZE OF A NEEDLE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MFR: 07/29/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER INSERTION INTO THE PT, AIR BUBBLES WERE OBSERVED ON THE ARM OF THE STOPCOCK TUBE WHEN THE PHYSICIAN WAS ATTEMPTING TO FLUSH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO SWARTZ BRAID INT 8F SLO DYB ST. JUDE MEDICAL, AF DIV 407449 2927115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK