BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    MDR report key: 2172196 · Received June 15, 2011

    Report

    Report Number
    3005188751-2011-00106
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    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

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS ATTEMPTING TO PERFORM A TRANSSEPTAL PUNCTURE AND SKIVING OCCURRED INSIDE OF THE INTRODUCER SHEATH. ADD'L INFO WAS REQUESTED AND IS NOT AVAILABLE.

    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 DIVISION 406840 3320356

    Patients

    Seq Age Sex Outcome Treatment
    1 ST JUDE MEDICAL BRK NEEDLE, REORDER AND LOT UNK