BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB

    MDR report key: 2031058 · Received March 22, 2011

    Report

    Report Number
    2030404-2011-00075
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AS MFR REPORT#: 3005188751-2011-00036, 3005188751-2011-00035, 3005188751-2011-00037, 3005188751-2011-00038, 3005188751-2011-00039 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 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83563 3185674

    Patients

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