BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED TRANS. GUIDING INT. 8F, SLO

    MDR report key: 3052987 · Received April 5, 2013

    Report

    Report Number
    3005188751-2013-00051
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS AN INHERENT RISK OF ANY TRANSSEPTAL PROCEDURE.

    Description of Event or Problem · 1

    RELATED TO MFR REFERENCE 2030404-2013-00027. DURING A LEFT ATRIAL FLUTTER ABLATION UNDER GENERAL ANESTHESIA USING A THERAPY COOL FLEX ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. THROUGHOUT THE PROCEDURE, HEPARIN WAS TITRATED TO KEEP THE ACT AT THE TARGET OF 300 SECONDS. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY, BUT A ROUTINE POST-PROCEDURE ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT. A PERICARDIOCENTESIS WAS PERFORMED IN SURGERY AND THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS SUCCESSFULLY RESUSCITATED BUT IS NOW IN A COMATOSE STATE WITH NEUROLOGICAL DEFICITS. FURTHER INFORMATION WAS REQUESTED BUT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142004 SWARTZ BRAIDED TRANS. GUIDING INT. 8F, SLO TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407449 3905007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COOL FLEX ABLATION CATHETER ((B)(4))