BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F

    MDR report key: 4197378 · Received October 23, 2014

    Report

    Report Number
    3005188751-2014-00125
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    PK061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC TAMPONADE 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 2030404-2014-00094, 2030404-2014-00095, 2030404-2014-00096, 3005188751-2014-00126. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. AN INQUIRY EP CATHETER WAS ADVANCED INTO THE CORONARY SINUS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE AND A THERAPY COOL FLEX ABLATION CATHETER WAS ADVANCED THROUGH AN AGILIS NXT INTRODUCER TO THE LEFT ATRIUM. THE PATIENT WAS RESTLESS DURING THE PROCEDURE AND, AFTER APPROXIMATELY TWO HOURS, BECAME INCREASINGLY HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS THEN PERFORMED, WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676136 AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 408310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIOSENSE WEBSTER STOCKERT GENERATOR| GE/PRUCKA RECORDING SYSTEM| INQUIRY OPTIMA EP CATHETER| ENSITE VELOCITY MAPPING SYSTEM| SENSITHERM ESOPHAGEAL TEMPERATURE PROBE| THERAPY COOL FLEX ABLATION CATHETER| INQUIRY DECAPOLAR EP CATHETER| BRK TRANSSEPTAL NEEDLE