BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18938492 · Received March 20, 2024

    Report

    Report Number
    2029046-2024-00938
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    November 2, 2023
    Report Date
    March 19, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009163
    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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEI HQ, CHEN W, LUO S, LIAO Z, FANG X, LIAO H, SUN Q, GUO XG, YANG JD, LIANG JJ, WU S, XUE Y, MA J, ZHAN X. COMPARISON OF STRATEGIES FOR CATHETER ABLATION OF LEFT POSTERIOR FASCICULAR VENTRICULAR TACHYCARDIA. EUROPACE. 2023 NOV 2;25(11):EUAD339. DOI: 10.1093/EUROPACE/EUAD339. PMID: 37971899; PMCID: PMC10653165. E 1. INITIAL REPORTER PHONE: (B)(6). 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 NO LOT NUMBER WAS 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 REF # (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEI HQ, CHEN W, LUO S, LIAO Z, FANG X, LIAO H, SUN Q, GUO XG, YANG JD, LIANG JJ, WU S, XUE Y, MA J, ZHAN X. COMPARISON OF STRATEGIES FOR CATHETER ABLATION OF LEFT POSTERIOR FASCICULAR VENTRICULAR TACHYCARDIA. EUROPACE. 2023 NOV 2;25(11):EUAD339. DOI: 10.1093/EUROPACE/EUAD339. PMID: 37971899; PMCID: PMC10653165. OBJECTIVE/METHODS/STUDY DATA: AIMS: TRADITIONAL ABLATION STRATEGIES INCLUDING TARGETING THE EARLIEST PURKINJE POTENTIAL (PP) DURING LEFT POSTERIOR FASCICULAR (LPF) VENTRICULAR TACHYCARDIA (VT) OR LINEAR ABLATION AT THE MIDDLE SEGMENT OF LPF DURING SINUS RHYTHM ARE COMMONLY USED FOR THE TREATMENT OF LPF-VT. CATHETER ABLATION FOR LPF-VT TARGETING FRAGMENTED ANTEGRADE PURKINJE (FAP) POTENTIAL DURING SINUS RHYTHM IS A NOVEL APPROACH. AUTHORS AIMED TO COMPARE SAFETY AND EFFICACY OF DIFFERENT ABLATION STRATEGIES (FAP ABLATION VS. TRADITIONAL ABLATION) FOR THE TREATMENT OF LPF-VT. METHODS AND RESULTS: CONSECUTIVE PATIENTS WITH ELECTROCARDIOGRAPHICALLY DOCUMENTED LPF-VT REFERRED FOR CATHETER ABLATION RECEIVED EITHER FAP ABLATION APPROACH OR TRADITIONAL ABLATION APPROACH. ELECTROPHYSIOLOGICAL CHARACTERISTICS, PROCEDURAL COMPLICATIONS, AND LONG-TERM CLINICAL OUTCOME WERE ASSESSED. A TOTAL OF 189 CONSECUTIVE PATIENTS WHO UNDERWENT CATHETER ABLATION FOR LPF-VT WERE INCLUDED. FRAGMENTED ANTEGRADE PURKINJE ABLATION WAS ATTEMPTED IN 95 PATIENTS, AND TRADITIONAL ABLATION WAS ATTEMPTED IN 94 PATIENTS. ACUTE ABLATION SUCCESS WITH ELIMINATION OF LPF-VT WAS ACHIEVED IN ALL PATIENTS. LEFT POSTERIOR FASCICULAR BLOCK OCCURRED IN 11 OF 95 (11.6%) PATIENTS IN THE FAP GROUP COMPARED WITH 75 OF 94 (79.8%) PATIENTS IN THE TRADITIONAL GROUP (P < 0.001). FRAGMENTED ANTEGRADE PURKINJE ABLATION WAS ASSOCIATED WITH SIGNIFICANT SHORTER PROCEDURE TIME (94 ± 26 VS. 117 ± 23 MIN, P = 0.03) AND FEWER RADIOFREQUENCY ENERGY APPLICATIONS (4.1 ± 2.4 VS. 6.3 ± 3.5, P = 0.003) COMPARED WITH THE TRADITIONAL GROUP. ONE COMPLETE ATRIOVENTRICULAR BLOCK AND ONE LEFT BUNDLE BRANCH BLOCK WERE SEEN IN THE TRADITIONAL GROUP. OVER MEAN FOLLOW-UP OF 65 MONTHS, 89 (93.7%) PATIENTS IN THE FAP GROUP AND 81 (86.2%) PATIENTS IN THE TRADITIONAL GROUP REMAINED FREE OF RECURRENT VT OFF ANTIARRHYTHMIC DRUGS (P = 0.157). CONCLUSION: LEFT POSTERIOR FASCICULAR-VENTRICULAR TACHYCARDIA ABLATION UTILIZING FAP AND TRADITIONAL ABLATION APPROACHES RESULTED IN SIMILAR ACUTE AND LONG-TERM PROCEDURAL OUTCOMES. SERIOUS HIS-PURKINJE INJURY DID OCCUR INFREQUENTLY DURING TRADITIONAL ABLATION. THE USE OF FAP ABLATION APPROACH WAS ASSOCIATED WITH SHORTER PROCEDURE TIME AND FEWER RADIOFREQUENCY ENERGY APPLICATIONS, ESPECIALLY FOR NON-INDUCIBLE PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO MAPPING SYSTEM CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER: QTY 1 SERIOUS HIS PURKINJE INJURY WHERE A COMPLETE ATRIOVENTRICULAR BLOCK (HEART BLOCK AV) OCCURRED AND REQUIRED PACEMAKER IMPLANT (SURGICAL INTERVENTION) QTY 1 SERIOUS HIS PURKINJE INJURY WERE LEFT BUNDLE BRANCH BLOCK OCCURRED (HEART BLOCK) (RECOGNIZED PROCEDURAL COMPLICATION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755297 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L UNK_CARTO 3.