BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14727470 · Received June 17, 2022

    Report

    Report Number
    2029046-2022-01358
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    October 14, 2021
    Report Date
    June 17, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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: YOU L, ZHANG X, YANG J, WANG L, ZHANG Y, XIE R. THE LONG-TERM RESULTS OF THREE CATHETER ABLATION METHODS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION: A 4-YEAR FOLLOW-UP STUDY. FRONT CARDIOVASC MED. 2021 OCT 14;8:719452. DOI: 10.3389/FCVM.2021.719452. PMID: 34722655; PMCID: PMC8551484. OBJECTIVE/METHODS/STUDY DATA: AIMS: CATHETER ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION (PAF) HAS BEEN SHOWN TO BE EFFECTIVE AND SAFE. HOWEVER, RECURRENCE OF PAF VARIES BETWEEN 10 AND 30% FOR RADIOFREQUENCY ABLATION. THERE HAVE BEEN NO REPORTS COMPARING LONG-TERM RECURRENCE RATES FOLLOWING RADIOFREQUENCY ABLATION, CRYOABLATION, AND THREE-DIMENSIONAL GUIDED CRYOABLATION PLUS RADIOFREQUENCY ABLATION. THE AIM OF THIS STUDY WAS TO OBSERVE THE LONG-TERM RECURRENCE RATE OF PAF WHEN TREATED BY THESE THREE CATHETER ABLATION METHODS, AND TO EXPLORE CLINICAL FACTORS THAT CAN POTENTIALLY PREDICT PAF RECURRENCE FOLLOWING CATHETER ABLATION. METHODS: THERE WERE 238 PATIENTS INVOLVED IN THIS STUDY, INCLUDING 106 RADIOFREQUENCY (RF) ABLATION CASES (RF GROUP), 66 CRYOABLATION CASES (FREEZE GROUP), AND 66 CASES TREATED BY THREE-DIMENSIONAL GUIDED CRYOABLATION COMBINED WITH RADIOFREQUENCY ABLATION (FREEZE-PLUS-RF GROUP). ALL PATIENTS UNDERWENT STANDARDIZED FOLLOW-UP. THE RECURRENCE RATE OF ATRIAL FIBRILLATION (AF) IN THE THREE GROUPS WAS CALCULATED. PREDICTIVE FACTORS FOR THE RECURRENCE OF AF WERE ALSO INVESTIGATED. RESULTS: AT 48 MONTHS (THE MEDIAN FOLLOW-UP PERIOD), THE SINUS RHYTHM MAINTENANCE RATE WAS 77.4% IN THE RF GROUP, 72.7% IN THE FREEZE GROUP, AND 81.8% IN THE FREEZE-PLUS-RF GROUP. THE MAINTENANCE RATE OF SINUS RHYTHM WAS HIGHEST IN THE FREEZE-PLUS-RF GROUP, BUT DIFFERENCES AMONG THE THREE GROUPS WERE NOT STATISTICALLY SIGNIFICANT. FURTHER ANALYSIS FOUND THAT THE PREOPERATIVE LEFT ATRIAL APPENDAGE EMPTYING VELOCITY (LAAEV) (RECURRENCE VS. NO RECURRENCE, 56.58 ± 18.37 VS. 65.59 ± 18.83, RESPECTIVELY, P = 0.003), LEFT ATRIAL (LA) ANTEROPOSTERIOR DIMENSION (RECURRENCE VS. NO RECURRENCE, 36.56 ± 4.65 VS. 35.00 ± 4.37, RESPECTIVELY; P = 0.028), AND LA VERTICAL DIMENSION (RECURRENCE VS. NO RECURRENCE, 56.31 ± 6.96 VS. 53.72 ± 6.52, RESPECTIVELY; P = 0.035) WERE RELATED TO POSTOPERATIVE RECURRENCE. MULTIPLE COX REGRESSION ANALYSIS SHOWED THAT ONLY LAAEV WAS PREDICTIVE OF POSTOPERATIVE RECURRENCE OF PAF. CONCLUSION: THE STUDY FOUND THAT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN LONG-TERM RECURRENCE RATES AMONG THE RF, FREEZE, AND FREEZE-PLUS-RF GROUPS. PREOPERATIVE LAAEV IS AN INDEPENDENT PREDICTOR OF POSTOPERATIVE RECURRENCE OF PAF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH, BIOSENSE WEBSTER, OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: -CARTO 3, -LASSO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ARCTIC FRONT ADVANCE TM, ENSITE NAVX 3D, ACHIEVE, MEDTRONIC. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PATIENT DEVELOPED PERICARDIAL EFFUSION 2 H AFTER THE OPERATION AND RECOVERED AFTER PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397319 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 ACHIEVE, MEDTRONIC| ARCTIC FRONT ADVANCE TM| CARTO 3| ENSITE NAVX 3D| LASSO