BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIS¿ INTRODUCER, UNKNOWN

    MDR report key: 8752507 · Received July 2, 2019

    Report

    Report Number
    2182269-2019-00089
    Event Type
    Death
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER IS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ABBOTT, THE CAUSE OF REPORTED CARDIAC PERFORATION AND SUBSEQUENT DEATH COULD NOT BE CONFIRMED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT FURTHER INFORMATION REGARDING THE EVENT WERE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 3005334138-2019-00345, 2030404-2019-00051, 2030404-2019-00052. DURING A LEFT ATRIAL FLUTTER ABLATION PROCEDURE, A CARDIAC PERFORATION AND SUBSEQUENT DEATH OCCURRED. FOLLOWING ABLATION IN THE LEFT ATRIUM, THE CAVO-TRICUSPID ISTHMUS LINE ABLATION WAS CONTINUED IN THE RIGHT ATRIUM. AN AUDIBLE STEAM POP OCCURRED. THE PROCEDURE WAS PAUSED, THE PATIENT WAS ASSESSED, AND THE PROCEDURE CONTINUED. TWO ADDITIONAL STEAM POPS WERE NOTED AND THE PROCEDURE CONTINUED. ICE IMAGING NOTED AN EFFUSION ON THE RIGHT SIDE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS FOLLOWED WITH SURGICAL INTERVENTION, HOWEVER EXPIRED INTRA-OPERATIVE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546851 AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER DYB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R INQUIRY¿ STEERABLE EP CATHETER| TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE| VIEWFLEX¿ICE CATHETER| INQUIRY¿ STEERABLE EP CATHETER| TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE| VIEWFLEX¿ICE CATHETER