BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17135339 · Received June 15, 2023

    Report

    Report Number
    2029046-2023-01297
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    April 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: MÜLLER J, NENTWICH K, BERKOVITZ A, ENE E, SONNE K, ZHURAVLEV V, CHAKAROV I, BARTH S, WAECHTER C, BEHNES M, HALBFASS P, DENEKE T. ACUTE OESOPHAGEAL SAFETY AND LONG-TERM FOLLOW-UP OF AI-GUIDED HIGH-POWER SHORT-DURATION WITH 50 W FOR ATRIAL FIBRILLATION ABLATION. EUROPACE. 2023 APR 15;25(4):1379-1391. DOI: 10.1093/EUROPACE/EUAD053. PMID: 36881791; PMCID: PMC10105862. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMS TO COMPARE EFFICACY AND SAFETY OF TWO DIFFERENT HPSD ABLATION APPROACHES USING DIFFERENT ABLATION INDEX SETTINGS. 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: MÜLLER J, NENTWICH K, BERKOVITZ A, ENE E, SONNE K, ZHURAVLEV V, CHAKAROV I, BARTH S, WAECHTER C, BEHNES M, HALBFASS P, DENEKE T. ACUTE OESOPHAGEAL SAFETY AND LONG-TERM FOLLOW-UP OF AI-GUIDED HIGH-POWER SHORT-DURATION WITH 50 W FOR ATRIAL FIBRILLATION ABLATION. EUROPACE. 2023 APR 15;25(4):1379-1391. DOI: 10.1093/EUROPACE/EUAD053. PMID: 36881791; PMCID: PMC10105862. OBJECTIVE/METHODS/STUDY DATA:THIS STUDY AIMS TO COMPARE EFFICACY AND SAFETY OF TWO DIFFERENT HPSD ABLATION APPROACHES USING DIFFERENT ABLATION INDEX SETTINGS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: STANDARD ABLATION CATHETER (THERMOCOOL SMARTTOUCH SF; BIOSENSE WEBSTER, IRVINE, CALIFORNIA, USA). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ELECTROANATOMIC MAPPING SYSTEM (CARTO 3, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) IN CONJUNCTION WITH A DECAPOLAR MAPPING CATHETER (LASSO; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) OR IN SELECTED PATIENTS WITH A MULTIPOLAR HIGH-DENSITY MAPPING CATHETER (PENTARAY; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA), MARTABLATE GENERATOR (BIOSENSE WEBSTER, IRVINE, CALIFORNIA, USA NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEERABLE 11.7-FRENCH SHEATH WAS PERFORMED (AGILIS, ABBOTT, MINNEAPOLIS, MN, USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PERICARDIAL TAMPONADE THREE PATIENTS SUFFERED THROMBOEMBOLIC COMPLICATIONS (ONE TRANSITORY ISCHAEMIC ATTACK 3 DAYS AFTER PVI WITHOUT CT OR MRI IMAGING CORRELATE; ONE PATIENT WITH HEMIPARESIS THE DAY AFTER PVI PROVEN VIA CT AND MRI, AND ONE PATIENT WITH HEMIPLEGIA AFTER THE PVI PROVEN WITH MRI). FOUR PATIENTS SUFFERED FROM POST-CONVERSION SYMPTOMATIC BRADYCARDIA (UNMASKED SINUS NODE DYSFUNCTION) AND REQUIRED PACEMAKER IMPLANTATIONS AFTER THE ABLATION PROCEDURE. FOUR PATIENTS WITH ASPIRATION PNEUMONIA. TWO PATIENTS WITH AIR EMBOLISM. ONE PATIENT WITH PHRENICUS PARESIS - NO TREATMENT INDICATED. 98 PATIENTS WITH EDEL OR THERMAL OESOPHAGUS LESIONS -NO TREATMENT INDICATED. TWO PATIENTS SUFFERED FROM POST-INTERVENTIONAL STROKE. ONE PATIENT WITH HEMIPLEGIA WITH ISCHAEMIA - NO TREATMENT INDICATED. ONE PATIENT WITH SEIZURES WITH ISCHAEMIA - NO TREATMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103600 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L DECAPOLAR MAPPING CATHETER (LASSO)| ELECTROANATOMIC MAPPING SYSTEM (CARTO 3)| MULTIPOLAR HIGH-DENSITY MAPPING CATH (PENTARAY)| SMARTABLATE GENERATOR| STEERABLE 11.7-FRENCH SHEATH (AGILIS, ABBOTT,)| UNK_SMARTABLATE PUMP