BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    MDR report key: 2182225 · Received July 12, 2011

    Report

    Report Number
    3005188751-2011-00111
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIV
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED DEVICE REVEALED SKIVING. ONE 8F SWARTZ INTRODUCER WITH THE DILATOR FULLY INSERTED WAS RECEIVED FOR EVAL. A .032 INCH GUIDEWIRE WAS OBTAINED FROM CURRENT INVENTORY AND INSERTED INTO THE DILATOR. WHEN ADVANCING, RESISTANCE WAS ENCOUNTERED NEAR THE DISTAL END OF THE DILATOR. THE DISTAL 3 INCHES OF THE DILATOR WERE REMOVED AND CROSS SECTIONED OPEN, WHICH REVEALED DEEP GROOVES AND CURLED MATERIAL FROM THE INNER WALL OF THE DILATOR PREVENTING ADVANCEMENT OF THE GUIDEWIRE. THE TRANSSEPTAL NEEDLE USED IN CONJUNCTION WITH THIS INTRODUCER WAS NOT RETURNED, WHICH MAY HAVE AIDED IN A MORE THOROUGH INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEEDLE THROUGH THE SHEATH, THE SHEATH APPEARED BLOCKED. ANOTHER SJM BRK NEEDLE (REORDER AND LOT NUMBER UNK) WAS OBTAINED AND USED WITH THE INTRODUCER TO CONTINUE THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PT. DEVICE ANALYSIS REVEALED SKIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F SWARTZ TRANSSEPTAL SL1 DYB ST. JUDE MEDICAL, AF DIV 406840 3320356

    Patients

    Seq Age Sex Outcome Treatment
    1 SJM BRK NEEDLE: UNK REORDER AND LOT