BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2031195 · Received March 22, 2011

    Report

    Report Number
    3005188751-2011-00035
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL/LOT NUMBER IS UNKNOWN. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AS MFR REPORT#: 3005188751-2011-00036, 300518751-2011-00037, 3005188751-2011-00038, 3005188751-2011-00039, 2030404-2011-00075, AND 2030404-2011-00079. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, DURING THE RECONSTRUCTION OF THE ANATOMY, THE DOCTOR DETECTED A POSSIBLE HEMORRHAGE IN THE PERICARDIUM. THIS WAS CONFIRMED WITH ULTRASOUND AND THE CASE WAS ABORTED. NO FURTHER TREATMENT WAS NECESSARY BUT THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION AND IS STABLE.

    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, AF DIVISION 406849 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other BRK TRANSSEPTAL NEEDLE: (B)(4), LOT 3179662| COOL PATH DUO 7F: (B)(4), LOT 3185674| FAST-CATH INTRODUCER: (B)(4), LOT 3088538| FAST-CATH INTRODUCER: (B)(4), LOT 3134690| POLYHESIVE RETURN ELECTRODE: (B)(4), LOT 19409| LIVEWIRE EP CATHETER: (B)(4), LOT 3124488| COOL PATH DUO 7F CATHETER: (B)(4), LOT 3185673| COOL POINT TUBING: (B)(4), (B)(4)| NAVX PATCHES: (B)(4), LOT 3246678