BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 16188506 · Received January 17, 2023

    Report

    Report Number
    3008452825-2022-00740
    Event Type
    Death
    Date Received
    January 17, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 19, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027689
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. HOWEVER, DUE TO UNKNOWN PROCEDURAL CONDITIONS WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED INCIDENT UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2023-00014, 3005334138-2023-00013. DURING PVC ABLATION, A LARGE PERICARDIAL EFFUSION OCCURRED REQUIRING PERICARDIOCENTESIS AND CPR AND RESULTED IN THE DEATH OF THE PATIENT. WHILE PERFORMING A PVC ABLATION IN THE LEFT VENTRICLE VIA RETROGRADE AORTIC APPROACH WITH A TACTICATH SE, A "STEAM POP" WAS NOTED TO OCCUR DURING THE FIRST APPLICATION OF ABLATION THERAPY WHILE THE CATHETER WAS PARALLEL TO THE ENDOCARDIUM IN TRABECULATED TISSUE. THE PATIENT'S BLOOD PRESSURE AND RHYTHM WERE STABLE, SO THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE. PRIOR TO ABLATION THERAPY, IT WAS NOTED TO THE PHYSICIAN THAT THE TACTICATH SE CONTACT FORCE SETTING WAS NOT YET ZEROED PRIOR TO GOING IN-VIVO, AND WAS ALSO UNSUCCESSFUL AT FINDING A CONTACTLESS POSITION WITHIN THE VENTRICLE TO PERFORM AN INTERNAL ZERO, HOWEVER THE PHYSICIAN DECIDED TO CONTINUE WITHOUT ZEROING THE TACTICATH SE CONTACT FORCE READING. PRIOR TO GOING TRANSSEPTAL, ABLATION WAS TAKING PLACE MID BASAL AND INFERO-SEPTAL IN THE LEFT VENTRICLE VIA THE RETROGRADE AORTIC APPROACH FOR ROUGHLY AN HOUR. THE REMAINING RF APPLICATIONS TOOK PLACE NEAR OR AROUND THE SAME AREA. APPROXIMATELY NINE MORE RF APPLICATIONS WERE PERFORMED AFTER THE FIRST. AFTER SEVERAL UNSUCCESSFUL ABLATION THERAPY APPLICATIONS, THE PHYSICIAN DECIDED TO GO TRANSEPTAL TO TRY AND GET BETTER CONTACT ON THE TARGET SITE. AFTER ACHIEVING TRANSEPTAL ACCESS WITH A BRK NEEDLE AND SL CATHETER, THE SL WAS THEN EXCHANGED OVER A WIRE FOR A BSX DIREX STEERABLE SHEATH. WHEN THE PHYSICIAN LOOKED ON FLUOROSCOPY THE DEFLECT THE SHEATH TOWARD THE VENTRICLE, IT WAS OBSERVED THAT THE CATHETER AND HEART BORDERS WERE NOT MOVING. ICE IMAGE CONFIRMED A LARGE PERICARDIAL EFFUSION. THE SHEATH WAS REMOVED FROM THE LEFT ATRIUM, AND A PERICARDIOCENTESIS WAS PERFORMED. PROTAMINE WAS GIVEN AND CONTINUOUS CPR WAS THEN APPLIED WHILE THE PHYSICIAN CONTINUED TO EXTRACT FROM THE PERICARDIAL SPACE, WHILE ANESTHESIA MANAGED MEDICATIONS. BLOOD AND FFP'S WERE ALSO BEING INFUSED. THE PATIENT'S ACT AT THE TIME WAS 233. BP VIA CPR WAS IN THE 130-140'S. ROUGHLY 3000CC OF BLOOD WAS EXTRACTED FROM THE PERICARDIAL SPACE. THE PATIENT DID NOT SURVIVE. THERE WERE NO PERFORMANCE ISSUES WITH ANY DEVICE. THE NO CONTACT FORCE ISSUE WAS DUE TO THE USER NOT ZEROING THE DEVICE PRIOR TO USE. THE PHYSICIAN FEELS THE CAUSE OF PERFORATION MAY HAVE BEEN FROM EITHER THE TRANSSEPTAL ACCESS, OR JUST AFTER WHILE EXCHANGING THE SL1 SHEATH FOR THE BSX DIREX STEERABLE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109618 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL A-TCSE-D 8393665 05415067027689

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| D| O BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH| FAST-CATH INTRODUCER SWARTZ 8.5F