BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18943543 · Received March 20, 2024

    Report

    Report Number
    2029046-2024-00955
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    December 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DELLA ROCCA DG, MARCON L, MAGNOCAVALLO M, MENÈ R, PANNONE L, MOHANTY S, SOUSONIS V, SORGENTE A, ALMORAD A, BISIGNANI A, GLOWNIAK A, DEL MONTE A, BALA G, POLSELLI M, MOURAM S, LA FAZIA VF, STRÖKER E, GIANNI C, ZERIOUH S, BIANCHI S, SIEIRA J, COMBES S, SARKOZY A, ROSSI P, BOVEDA S, NATALE A, DE ASMUNDIS C, CHIERCHIA GB; HRMC INVESTIGATORS. PULSED ELECTRIC FIELD, CRYOBALLOON, AND RADIOFREQUENCY FOR PAROXYSMAL ATRIAL FIBRILLATION ABLATION: A PROPENSITY SCORE-MATCHED COMPARISON. EUROPACE. 2023 DEC 28;26(1):EUAE016. DOI: 10.1093/EUROPACE/EUAE016. PMID: 38245007; PMCID: PMC10823352. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DELLA ROCCA DG, MARCON L, MAGNOCAVALLO M, MENÈ R, PANNONE L, MOHANTY S, SOUSONIS V, SORGENTE A, ALMORAD A, BISIGNANI A, GLOWNIAK A, DEL MONTE A, BALA G, POLSELLI M, MOURAM S, LA FAZIA VF, STRÖKER E, GIANNI C, ZERIOUH S, BIANCHI S, SIEIRA J, COMBES S, SARKOZY A, ROSSI P, BOVEDA S, NATALE A, DE ASMUNDIS C, CHIERCHIA GB; HRMC INVESTIGATORS. PULSED ELECTRIC FIELD, CRYOBALLOON, AND RADIOFREQUENCY FOR PAROXYSMAL ATRIAL FIBRILLATION ABLATION: A PROPENSITY SCORE-MATCHED COMPARISON. EUROPACE. 2023 DEC 28;26(1):EUAE016. DOI: 10.1093/EUROPACE/EUAE016. PMID: 38245007; PMCID: PMC10823352. OBJECTIVE/METHODS/STUDY DATA: AIMS: PULSED FIELD ABLATION (PFA) HAS EMERGED AS A NOVEL, NON-THERMAL ENERGY SOURCE TO SELECTIVELY ABLATE CARDIAC TISSUE. AUTHORS DESCRIBE A MULTICENTRE EXPERIENCE ON PULMONARY VEIN ISOLATION (PVI) VIA THE PENTASPLINE FARAPULSE¿ PFA SYSTEM VS. THERMAL-BASED TECHNOLOGIES IN A PROPENSITY SCORE-MATCHED POPULATION OF PAROXYSMAL ATRIAL FIBRILLATION (PAF) PATIENTS. METHODS AND RESULTS: PROPENSITY SCORE MATCHING WAS ADOPTED TO COMPARE PVI-ONLY ABLATION OUTCOMES VIA THE FARAWAVE¿ SYSTEM (GROUP PFA), CRYOBALLOON (GROUP CRYO), OR FOCAL RADIOFREQUENCY (GROUP RF) (PFA:CRYO:RF RATIO = 1:2:2). AMONG 1572 (MEAN AGE: 62.4 ± 11.3 YEARS; 42.5% FEMALES) PAF PATIENTS UNDERGOING FIRST TIME PVI WITH EITHER PFA (N = 174), CRYO (N = 655), OR RF (N = 743), PROPENSITY SCORE MATCHING YIELDED 174 PFA, 348 CRYO, AND 348 RF PATIENTS. FIRST-PASS ISOLATION WAS ACHIEVED IN 98.8% OF PULMONARY VEINS (PVS) WITH PFA, 81.5% WITH CRYO, AND 73.1% WITH RF (P < 0.001). PROCEDURAL AND DWELL TIMES WERE SIGNIFICANTLY SHORTER WITH PFA, WHEREAS THE AVAILABILITY OF A 3D MAPPING SYSTEM LED TO A SIGNIFICANT REDUCTION IN X-RAY EXPOSURE WITH RF. OVERALL COMPLICATION RATES WERE 3.4% (N = 6) WITH PFA, 8.6% (N = 30) WITH CRYO, AND 5.5% (N = 19) WITH RF (P = 0.052). THE 1-YEAR KAPLAN-MEIER ESTIMATED FREEDOM FROM ANY ATRIAL TACHYARRHYTHMIA WAS 79.3% WITH PFA, 74.7% WITH CRYO, AND 72.4% WITH RF (LOG-RANK P-VALUE: 0.24). AMONG 145 REPEAT ABLATION PROCEDURES, PV RECONNECTION RATE WAS 19.1% AFTER PFA, 27.5% AFTER CRYO, AND 34.8% AFTER RF (P = 0.01). CONCLUSION: PULSED FIELD ABLATION CONTRIBUTED TO SIGNIFICANTLY SHORTER PROCEDURAL TIMES. FOLLOW-UP DATA SHOWED A SIMILAR ARRHYTHMIA FREEDOM, ALTHOUGH A HIGHER RATE OF PV RECONNECTION WAS DOCUMENTED IN POST-CRYO AND POST-RF REDO PROCEDURES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY IN RF GROUP: CARTO MAPPING SYSTEM, PENTARAY MAPPING CATHETER. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY IN RF GROUP: CIRCA S-CATH ESOPHAGEAL PROBE (SCIENTIFIC INC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER IN RF GROUP: QTY 1 STROKE/TIA/CVA (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION); QTY 11 (PERICARDITIS)(RECOGNIZED PROCEDURAL COMPLICATION); QTY 1 (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928792 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CIRCA S-CATH ESOPHAGEAL PROBE (SCIENTIFIC INC).| UNK_CARTO 3.| UNK_PENTARAY.