BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 3576813 · Received December 31, 2013

    Report

    Report Number
    3005188751-2013-00132
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RESULTS OF THE INVESTIGATIONS ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR ANALYSIS 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 PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN INHERENT RISK DURING THE USE OF THIS DEVICE IN THE HEART.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 3005188751-2013-00130, 3005188751-2013-000131-2013-00132, 2030404-2013-00130, 2030404-2013-00131, 2030404-2013-00132. DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN INQUIRY QUADRIPOLAR EP CATHETER WAS PLACED IN THE BUNDLE OF HIS AND ONE IN THE RIGHT VENTRICLE AND AN INQUIRY DECAPOLAR EP CATHETER WAS PLACED IN THE CORONARY SINUS. PVC MAPPING WAS PERFORMED USING ENSITE NAVX AND A TRANSSEPTAL PUNCTURE WAS PERFORMED TO MAP PVCS IN THE LEFT VENTRICULAR SEPTUM. ABLATION WAS PERFORMED WITH A SAFIRE ABLATION CATHETER. APPROXIMATELY 6 HOURS INTO THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ICE CATHETER WAS USED TO REVEAL A PERICARDIAL EFFUSION. HEPARIN WAS REVERSED AND A PERICARDIOCENTESIS WAS 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
    682991 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 408310 4241272

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SAFIRE ABLATION CATHETER| D087031/4270085| INQUIRY QUADRIPOLAR EP CATHETER| ENSITE NAVX MAPPING SYSTEM| BRK TRANSSEPTAL NEEDLE| 402809/4062622| INQUIRY DECAPOLAR EP CATHETER| 81404/3977839| VIEWFLEX XTRA ICE CATHETER| INQUIRY QUADRIPOLAR EP CATHETER| G407209/4045555| 81102/3974088| 81404/3977839