BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.

    MDR report key: 2822769 · Received November 2, 2012

    Report

    Report Number
    3005188751-2012-00297
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT SIDED ABLATION PROCEDURE, THE HEMOSTASIS VALVE OF A FAST-CATH INTRODUCER LEAKED. THE PHYSICIAN INSERTED A BRK NEEDLE INTO THE INTRODUCER AND COMPLETED A TRANSSEPTAL PUNCTURE. A GUIDEWIRE WAS ADVANCED THROUGH THE INTRODUCER. WHEN THE GUIDEWIRE AND THE DILATOR WERE REMOVED, A LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE INTRODUCER WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS. FAST-CATH TRANSSEPTAL DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 406849 3711311

    Patients

    Seq Age Sex Outcome Treatment
    1 BRK NEEDLE: MODEL 407200, LOT UNK