BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2031023 · Received March 22, 2011

    Report

    Report Number
    2030404-2011-00079
    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
    P06019
    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. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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. THE FOLLOWING DATES ARE ESTIMATED. ONLY THE MONTH/YEAR IS KNOWN: EXPIRATION DATE.

    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 2030404-2011-00075. 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 3185673

    Patients

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