BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17652495 · Received August 30, 2023

    Report

    Report Number
    2029046-2023-01937
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    May 16, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SOUSONIS V, COMBES S, PINON P, COMBES N, CARDIN C, ZERIOUH S, MENÈ R, JACOB S, BOVEDA S, ALBENQUE JP. A NOVEL STEPWISE APPROACH INCORPORATING ETHANOL INFUSION IN THE VEIN OF MARSHALL FOR THE ABLATION OF PERSISTENT ATRIAL FIBRILLATION. FRONT CARDIOVASC MED. 2023 MAY 16;10:1194687. DOI: 10.3389/FCVM.2023.1194687. PMID: 37304968; PMCID: PMC10251404. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SOUSONIS V, COMBES S, PINON P, COMBES N, CARDIN C, ZERIOUH S, MENÈ R, JACOB S, BOVEDA S, ALBENQUE JP. A NOVEL STEPWISE APPROACH INCORPORATING ETHANOL INFUSION IN THE VEIN OF MARSHALL FOR THE ABLATION OF PERSISTENT ATRIAL FIBRILLATION. FRONT CARDIOVASC MED. 2023 MAY 16;10:1194687. DOI: 10.3389/FCVM.2023.1194687. PMID: 37304968; PMCID: PMC10251404. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: APART FROM PULMONARY VEIN ISOLATION (PVI), SEVERAL STEP-BY-STEP PROCEDURES THAT AIM TO MODIFY LEFT ATRIAL SUBSTRATE HAVE BEEN PROPOSED FOR THE ABLATION OF PERSISTENT ATRIAL FIBRILLATION (AF), YET THE OPTIMAL STRATEGY REMAINS ELUSIVE. THERE ARE CUMULATIVE DATA SUGGESTING AN INCREMENTAL BENEFIT OF ADDING VEIN OF MARSHALL (VOM) ETHANOL INFUSION TO PVI IN PATIENTS WITH PERSISTENT AF. WE SOUGHT TO EVALUATE THE FEASIBILITY AND EFFICACY OF A NOVEL STEPWISE ABLATION APPROACH, INCORPORATING A VOM ALCOHOLIZATION STEP, FOR PERSISTENT AF. METHODS: IN THIS SINGLE-CENTER STUDY, WE PROSPECTIVELY ENROLLED 66 CONSECUTIVE PATIENTS WITH SYMPTOMATIC PERSISTENT AF AND FAILURE OF AT LEAST ONE ANTIARRHYTHMIC DRUG (ADD). THE ABLATION PROCEDURE CONSISTED OF (I) PVI, (II) LEFT ATRIAL SEGMENTATION WITH VOM ETHANOL INFUSION AND THE DEPLOYMENT OF LINEAR RADIOFREQUENCY LESIONS ACROSS THE ROOF AND THE MITRAL ISTHMUS AND (III) ELECTROGRAM-BASED ABLATION OF DISPERSION ZONES. THE FIRST TWO STEPS WERE PERFORMED IN ALL PATIENTS, WHEREAS THE THIRD STEP WAS CARRIED OUT ONLY IN THOSE STILL IN AF AT THE END OF THE SECOND STEP. ATRIAL TACHYCARDIAS DURING THE PROCEDURE WERE MAPPED AND ABLATED. AT THE END OF THE PROCEDURE, CAVOTRICUSPID ISTHMUS ABLATION WAS ADDITIONALLY PERFORMED IN ALL PATIENTS. THE PRIMARY ENDPOINT WAS 12-MONTH FREEDOM FROM AF AND ATRIAL TACHYCARDIA AFTER A SINGLE PROCEDURE AND AN INITIAL THREE-MONTH BLANKING PERIOD. RESULTS: TOTAL PROCEDURE TIME WAS 153 ± 38.5 MIN. FLUOROSCOPY TIME WAS 16 ± 6.5 MIN AND THE RADIOFREQUENCY ABLATION TIME WAS 26.14 ± 0.26 MIN. THE PRIMARY ENDPOINT OCCURRED IN 54 PATIENTS (82%). AT 12 MONTHS, 65% OF PATIENTS WERE OFF ANY AAD. IN THE UNIVARIATE COX REGRESSION ANALYSIS, LEFT VENTRICULAR EJECTION FRACTION < 40% WAS THE ONLY PREDICTOR OF ARRHYTHMIA RECURRENCE (HR 3.56; 95% CI, 1.04¿12.19; P = 0.04). ONE PATIENT DEVELOPED A PERICARDIAL TAMPONADE AND ANOTHER A MINOR GROIN HEMATOMA. CONCLUSION: A NOVEL STEPWISE APPROACH, INCLUDING A STEP OF ETHANOL INFUSION IN THE VOM, IS FEASIBLE, SAFE AND PROVIDES A HIGH RATE OF SINUS RHYTHM MAINTENANCE AT 12 MONTHS IN PATIENTS WITH PERSISTENT AF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: QDOT MICRO, WEBSTER CORONARY SINUS CATHETER, CARTO 3 MAPPING SYSTEM, PENTARAY MAPPING CATHETER, CARTOUNIVU MODULE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: A STEERABLE QUADRIPOLAR CORONARY SINUS CATHETER INQUIRYTM(ABBOTT); SWARTZ SL0 FIXED CURVE SHEATH (ABBOT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PATIENT DEVELOPED (CARDIAC TAMPONADE) REQUIRING PERICARDIOCENTESIS (RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287672 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO 3 MAPPING SYSTEM| CARTOUNIVU MODULE| PENTARAY MAPPING CATHETER| QDOT MICRO| STEERABLE QUAD CORONARY SINUS CATH (ABBOTT)| SWARTZ SL0 FIXED CURVE SHEATH (ABBOTT)| WEBSTER CORONARY SINUS CATHETER