BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVEWIRE EP CATHETER 5F, DECA, MED SWP, 2MM

    MDR report key: 2030976 · Received March 22, 2011

    Report

    Report Number
    3005188751-2011-00038
    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
    DRA
    PMA / PMN Number
    K913940
    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 DEVICES 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 IN THE IFU.

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AS MFR REPORT#: 3005188751-2011-00036, 3005188751-2011-00035, 3005188751-2011-00037, 3005188751-2011-00039, 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 LIVEWIRE EP CATHETER 5F, DECA, MED SWP, 2MM LIVEWIRE EP 5F, DECA DRA ST. JUDE MEDICAL, AF DIVISION 401940 3124488

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other COOL PATH DUO 7F CATHETER: REF 83563, LOT 3185673| NAVX PATCHES: REF EN0010-002, LOT 3246678| FAST-CATH INTRODUCER: REF 406849, LOT UNKNOWN| FAST-CATH INTRODUCER: REF 406849, LOT 3134690| COOL POINT TUBING: REF 85785, H168809| POLYHESIVE RETURN ELECTRODE: REF 85722, LOT 19409| COOL PATH DUO 7F: REF 83563, LOT 3185674| BRK TRANSSEPTAL NEEDLE: REF 407200, LOT 3179662| FAST-CATH INTRODUCER: REF 406849, LOT 3088538