BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D

    MDR report key: 8686262 · Received June 11, 2019

    Report

    Report Number
    3005334138-2019-00300
    Event Type
    Death
    Date Received
    June 11, 2019
    Date of Event
    May 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CAUSE OF THE REPORTED PULMONARY EDEMA AND SUBSEQUENT DEATH REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    RELATED MANUFACTURE REF: 3005334138-2019-00301, 2030404-2019-00043, 2030404-2019-00044, 3008452825-2019-00269. ONE DAY POST ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED ACUTE PULMONARY EDEMA AND EXPIRED. THE PATIENT HAD A HISTORY OF HEART FAILURE, THE CAUSE OF PULMONARY EDEMA IS UNKNOWN, THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482346 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D CARDIAC ABLATION PERCUTANEOUS CATHETER OAE ST. JUDE MEDICAL A-TCSE-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BRK XS TRANSSEPTAL NEEDLE| INQUIRY OPTIMA PLUS CATHETER| INQUIRY STEERABLE CATHETER| SWARTZ BRAIDED INTRODUCER