BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE¿ BLU¿ DUO ABLATION CATHETER IRRIGATED BI-DIRECTIONAL 4 MM TIP THERMOCOUPL

    MDR report key: 4197478 · Received October 23, 2014

    Report

    Report Number
    2030404-2014-00097
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.(AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    PP110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00127, 3005188751-2014-00128, 3005188751-2014-00129, 3005188751-2014-00130. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. TWO TRANSSEPTAL PUNCTURES WERE COMPLETED USING A BRK NEEDLE AND A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER. THE INTRODUCER WAS EXCHANGED WITH AN AGILIS NXT INTRODUCER, THROUGH WHICH A SAFIRE BLU DUO ABLATION CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. A REFLEXION SPIRAL EP CATHETER WAS ALSO ADVANCED INTO THE LEFT ATRIUM. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS NOTED VIA A NON-SJM ICE CATHETER. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. ONCE THE PATIENT WAS STABLE, A CAVOTRICUSPID ISTHMUS LINE ABLATION WAS PERFORMED. THE PATIENT REMAINED STABLE AND WAS TRANSFERRED TO THE ICU FOR OBSERVATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675269 SAFIRE¿ BLU¿ DUO ABLATION CATHETER IRRIGATED BI-DIRECTIONAL 4 MM TIP THERMOCOUPL CATHETER, PERCUTANEOUS CARDIAC ABLATION OAD ST. JUDE MEDICAL, INC.(AF-IRVINE) A088107 4677721

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention BRK TRANSSEPTAL NEEDLE| REFLEXION SPIRAL EP CATHETER| AGILIS NXT INTRODUCER| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER