BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 16871944 · Received May 4, 2023

    Report

    Report Number
    3005334138-2023-00187
    Event Type
    Injury
    Date Received
    May 4, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION RECEIVED CONFIRMED THAT THE PHYSICIAN ALLEGES THAT THE CARDIAC PERFORATION WAS DUE TO THE NON-ABBOTT DIAMOND TEMP CATHETER. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT PRODUCTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY 66.3: 551-559. SPRINGER. (APR 2023) "INITIAL EXPERIENCE OF TEMPERATURE-CONTROLLED IRRIGATED RADIOFREQUENCY ABLATION FOR ISCHAEMIC CARDIOMYOPATHY VENTRICULAR TACHYCARDIA ABLATION" AL-SHEIKHLI, JAFFAR. BACKGROUND: THE DIAMONDTEMP ABLATION (DTA) CATHETER SYSTEM DELIVERS HIGH POWER, OPEN-IRRIGATED, TEMPERATURE-CONTROLLED RADIOFREQUENCY (RF) ABLATION. THIS NOVEL ABLATION SYSTEM HAS NOT BEEN PREVIOUSLY USED FOR VENTRICULAR TACHYCARDIA (VT) ABLATION. OBJECTIVE: FEASIBILITY OF USING THE DTA CATHETER SYSTEM FOR VT ABLATION IN ISCHAEMIC CARDIOMYOPATHY (ICM) PATIENTS. METHOD: TEN ICM PATIENTS WITH OPTIMAL ANTI-ARRHYTHMIC DRUG THERAPY AND IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) WERE RECRUITED. VT INDUCIBILITY TESTING WAS PERFORMED AT THE END OF THE PROCEDURE. ICD DATA FOR DEVICE DETECTED VT EPISODES AND DEVICE TREATED VT EPISODES WERE COLLECTED FOR 6-MONTHS PRE- AND POST-ABLATION. RESULTS: SUBSTRATE ANALYSIS DEMONSTRATED REDUCTIONS IN THE BORDERZONE AREA OF 4.4 CM2 (P = 0.026) AND LATE POTENTIAL AREA OF 3.5 CM2 (P = 0.0449) POST-ABLATION, WITH REDUCTIONS IN THE MEAN BIPOLAR AND UNIPOLAR VOLTAGES OF THE ABLATION TARGET AREAS (0.14 MV (P = 0.0007); 0.59 MV (P = 0.0072) RESPECTIVELY). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 9 PROCEDURES. POST-ABLATION VT INDUCIBILITY TESTING WAS NOT PERFORMED IN 1 PROCEDURE DUE TO A STEAM POP COMPLICATION RESULTING IN PERICARDIAL TAMPONADE REQUIRING DRAINAGE. MEAN FOLLOW-UP OF 214 ± 33 DAYS REVEALED AN 88% REDUCTION IN TOTAL VT EPISODES (N = 266 MEDIAN 16 [IQR 3¿57] TO N = 33 MEDIAN 0; P = 0.0164) AND 77% REDUCTION IN ICD THERAPIES (N = 128 MEDIAN 5 [IQR 2¿15] TO N = 30 MEDIAN 0; P = 0.0181). CONCLUSION: THE DTA SYSTEM RESULTED IN ADEQUATE LESION CHARACTERISTICS WITH EFFECTIVE SUBSTRATE MODIFICATION, ACUTE PROCEDURAL SUCCESS AND IMPROVED OUTCOMES AT INTERMEDIATE-TERM FOLLOW-UP. RANDOMISED CONTROLLED TRIALS ARE REQUIRED TO COMPARE THE PERFORMANCE OF THE DTA SYSTEM AGAINST CONVENTIONAL ABLATION CATHETERS. ONE EVENT OF PERICARDIAL TAMPONADE OCCURRED DUE TO A STEAM POP AFTER 48 MIN OF ABLATION REQUIRING DRAINAGE. THE FINAL ABLATION LESION WITH A NON-ABBOTT (DIAMOND TEMP CATHETER) RESULTED IN A STEAM POP WHERE THE MAXIMUM TEMPERATURE REACHED WAS 60 °C WITH AN IMPEDANCE REDUCTION OF 20 O TARGETING THE VT ISTHMUS. PERICARDIAL TAMPONADE WAS CONFIRMED BY FLUORO AND ECHO FOLLOWED BY INTRAVENOUS PROTAMINE ADMINISTRATION TO REVERSE THE UNFRACTIONATED HEPARIN AS THE PERICARDIAL DRAIN WAS INSERTED. APPROXIMATELY 100 ML OF BLOOD WAS AUTO TRANSFUSED AND THE PATIENT STABILIZED. THE DRAIN WAS REMOVED THE FOLLOWING DAY AND THE PATIENT RECOVERED WELL. THE PHYSICIAN ALLEGES THE CARDIAC PERFORATION WAS DUE TO USE OF THE DIAMOND TEMP CATHETER. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT PRODUCTS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY 66.3: 551-559. SPRINGER. (APR 2023) "INITIAL EXPERIENCE OF TEMPERATURE-CONTROLLED IRRIGATED RADIOFREQUENCY ABLATION FOR ISCHAEMIC CARDIOMYOPATHY VENTRICULAR TACHYCARDIA ABLATION" AL-SHEIKHLI, JAFFAR. BACKGROUND: THE DIAMONDTEMP ABLATION (DTA) CATHETER SYSTEM DELIVERS HIGH POWER, OPEN-IRRIGATED, TEMPERATURE-CONTROLLED RADIOFREQUENCY (RF) ABLATION. THIS NOVEL ABLATION SYSTEM HAS NOT BEEN PREVIOUSLY USED FOR VENTRICULAR TACHYCARDIA (VT) ABLATION. OBJECTIVE: FEASIBILITY OF USING THE DTA CATHETER SYSTEM FOR VT ABLATION IN ISCHAEMIC CARDIOMYOPATHY (ICM) PATIENTS. METHOD: TEN ICM PATIENTS WITH OPTIMAL ANTI-ARRHYTHMIC DRUG THERAPY AND IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) WERE RECRUITED. VT INDUCIBILITY TESTING WAS PERFORMED AT THE END OF THE PROCEDURE. ICD DATA FOR DEVICE DETECTED VT EPISODES AND DEVICE TREATED VT EPISODES WERE COLLECTED FOR 6-MONTHS PRE- AND POST-ABLATION. RESULTS: SUBSTRATE ANALYSIS DEMONSTRATED REDUCTIONS IN THE BORDERZONE AREA OF 4.4 CM2 (P = 0.026) AND LATE POTENTIAL AREA OF 3.5 CM2 (P = 0.0449) POST-ABLATION, WITH REDUCTIONS IN THE MEAN BIPOLAR AND UNIPOLAR VOLTAGES OF THE ABLATION TARGET AREAS (0.14 MV (P = 0.0007); 0.59 MV (P = 0.0072) RESPECTIVELY). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 9 PROCEDURES. POST-ABLATION VT INDUCIBILITY TESTING WAS NOT PERFORMED IN 1 PROCEDURE DUE TO A STEAM POP COMPLICATION RESULTING IN PERICARDIAL TAMPONADE REQUIRING DRAINAGE. MEAN FOLLOW-UP OF 214 ± 33 DAYS REVEALED AN 88% REDUCTION IN TOTAL VT EPISODES (N = 266 MEDIAN 16 [IQR 3¿57] TO N = 33 MEDIAN 0; P = 0.0164) AND 77% REDUCTION IN ICD THERAPIES (N = 128 MEDIAN 5 [IQR 2¿15] TO N = 30 MEDIAN 0; P = 0.0181). CONCLUSION: THE DTA SYSTEM RESULTED IN ADEQUATE LESION CHARACTERISTICS WITH EFFECTIVE SUBSTRATE MODIFICATION, ACUTE PROCEDURAL SUCCESS AND IMPROVED OUTCOMES AT INTERMEDIATE-TERM FOLLOW-UP. RANDOMISED CONTROLLED TRIALS ARE REQUIRED TO COMPARE THE PERFORMANCE OF THE DTA SYSTEM AGAINST CONVENTIONAL ABLATION CATHETERS. ONE EVENT OF PERICARDIAL TAMPONADE OCCURRED DUE TO A STEAM POP AFTER 48 MIN OF ABLATION REQUIRING DRAINAGE. THE FINAL ABLATION LESION RESULTED IN A STEAM POP WHERE THE MAXIMUM TEMPERATURE REACHED WAS 60 °C WITH AN IMPEDANCE REDUCTION OF 20 O TARGETING THE VT ISTHMUS. PERICARDIAL TAMPONADE WAS CONFIRMED FOLLOWED BY INTRAVENOUS PROTAMINE ADMINISTRATION TO REVERSE THE UNFRACTIONATED HEPARIN AS THE PERICARDIAL DRAIN WAS INSERTED. APPROXIMATELY 100 ML OF BLOOD WAS AUTOTRANSFUSED AND THE PATIENT STABILIZED. THE DRAIN WAS REMOVED THE FOLLOWING DAY AND THE PATIENT RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620058 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown