BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH SWARTZ, HEMO INT SWARTZ SRO, 8F, 63CM

    MDR report key: 2111253 · Received April 28, 2011

    Report

    Report Number
    3005188751-2011-00045
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. THE CAUSE FOR THE REPORTED LEAK REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PHYSICIAN INSERTED AN ABLATION CATHETER INTO THE SHEATH, AIR WAS FOUND IN THE SHEATH. ANOTHER DEVICE CAME FROM THE SAME MODEL, DIFFERENT LOT WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH SWARTZ, HEMO INT SWARTZ SRO, 8F, 63CM SWARTZ SRO, 8F DYB ST. JUDE MEDICAL, AF DIVISION 406844 3228707

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR