BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ BRAIDED TRANS. GUIDING INT., 8F, LAMP 90

    MDR report key: 1883075 · Received October 15, 2010

    Report

    Report Number
    3005188751-2010-00106
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    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

    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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 10/15/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AIR WAS ASPIRATED THROUGH THE STOPCOCK DURING THE PROCEDURE. THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO FURTHER PROBLEMS. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANS. GUIDING INT., 8F, LAMP 90 SWARTZ INT, 8F, LAMP DYB ST. JUDE MEDICAL, AF DIVISION G407373 2858955

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK