BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 8752501 · Received July 2, 2019

    Report

    Report Number
    3005334138-2019-00345
    Event Type
    Death
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THE LOG FILES FROM THE TACTISYS QUARTZ SYSTEM WERE RETURNED. THE LOG FILE ANALYSIS CONCLUDED THAT THE TACTICATH CATHETER PERFORMED AS INTENDED. THE OPTICAL FIBERS MET SPECIFICATIONS, THE RECORDED TEMPERATURES INDICATED COOLING DURING RF ABLATION, AND CONTACT FORCE MEASUREMENTS WERE DISPLAYED THROUGHOUT THE DURATION OF THE LOG FILES. FORCE MEASUREMENTS WERE RECORDED DURING ABLATION THAT EXCEEDED THE RECOMMENDED VALUES IN THE TACTICATH SE CONTACT FORCE ABLATION CATHETER INSTRUCTIONS FOR USE (IFU); HOWEVER, DUE TO UNKNOWN PROCEDURAL CONDITIONS WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT.  A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER IS UNAVAILABLE. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE. THE CAUSE OF THE REPORTED CARDIAC PERFORATION AND SUBSEQUENT DEATH REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THE EVENT WERE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 2030404-2019-00051, 2182269-2019-00089, 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
    546847 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CARDIAC ABLATION PERCUTANEOUS CATHETER OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R AGILIS¿ INTRODUCER.| INQUIRY¿ STEERABLE EP CATHETER.| VIEWFLEX¿ICE CATHETER.| AGILIS¿ INTRODUCER| INQUIRY¿ STEERABLE EP CATHETER| VIEWFLEX¿ICE CATHETER