BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 17952933 · Received October 17, 2023

    Report

    Report Number
    2029046-2023-02343
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 17, 2023
    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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LIU J, GUAN W, GUO J, LI X, XIA Y, NIU G, YAO Y. OPTIMIZATION OF SUPERIOR VENA CAVA ISOLATION WITH AID OF ABLATION INDEX GUIDANCE. J CARDIOVASC ELECTROPHYSIOL. 2023 SEP;34(9):1820-1827. DOI: 10.1111/JCE.16006. EPUB 2023 JUL 26. PMID: 37493500. 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 PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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: LIU J, GUAN W, GUO J, LI X, XIA Y, NIU G, YAO Y. OPTIMIZATION OF SUPERIOR VENA CAVA ISOLATION WITH AID OF ABLATION INDEX GUIDANCE. J CARDIOVASC ELECTROPHYSIOL. 2023 SEP;34(9):1820-1827. DOI: 10.1111/JCE.16006. EPUB 2023 JUL 26. PMID: 37493500. OBJECTIVE/METHODS/STUDY DATA:INTRODUCTION: TO INVESTIGATE THE OPTIMAL RANGE OF QUANTITATIVE ABLATION INDEX (AI) VALUE DURING SUPERIOR VENA CAVA (SVC) ELECTRICAL ISOLATION BY RADIOFREQUENCY CATHETER ABLATION (RFCA). METHODS: FIRST, IN A DEVELOPMENT COHORT OF PATIENTS WITH ATRIAL FIBRILLATION (AF), THE RFCA WITH 40 W WAS PERFORMED TO COMPLETE SVC ISOLATION GUIDED BY THE CONDUCTION BREAKTHROUGH POINT FROM THE RIGHT ATRIUM TO SVC. THEN, THE RANGE OF AI VALUE WAS CALCULATED BY OFFLINE ANALYSIS ON DIFFERENT SEGMENTS OF SVC. LASTLY, FOR THE VALIDATION OF AF PATIENTS, THE SAFETY AND EFFECTIVENESS OF SVC ISOLATION WITH THE OPTIMIZED TARGET RANGE OF AI VALUE WERE EVALUATED WITH AN ADDITIONAL ADENOSINE TEST. RESULTS: A TOTAL OF 101 PATIENTS WITH AF WERE INCLUDED IN THE STUDY (44 PATIENTS IN THE DEVELOPMENT COHORT/57 IN THE VALIDATION COHORT). THE SEGMENTAL ABLATION STRATEGY WAS APPLIED IN 70% OF THE PATIENTS. ACCORDING TO THE OFFLINE ANALYSIS OF THE AI VALUES IN THE DEVELOPMENT COHORT, THE TARGET AI VALUE RANGE WAS SET AS 350¿400. THE SUCCESS RATE OF SVC ISOLATION IN THE VALIDATION COHORT WAS SIGNIFICANTLY HIGHER THAN THAT IN THE EXPLORATION COHORT (100% VS. 90.9%, P = .02), AND NO COMPLICATIONS OCCURRED IN THE EXPLORATION COHORT. DURING THE ADENOSINE TEST, THE RECOVERY RATE OF ELECTRICAL CONDUCTION IN SVC WAS SIGNIFICANTLY LOWER THAN THAT IN THE PULMONARY VEIN (3.5% VS. 17.5%). CONCLUSION: THE TARGET AI VALUE WITH A RANGE FROM 350 TO 400 IS SAFE AND EFFECTIVE FOR HIGH-POWER RFCA TO COMPLETE SVC ISOLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: (SMARTTOUCH OR SMARTTOUCH SF. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO MAPPING CATHETER, CARTO 3 SYSTEM WITH VISITAG. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED SMARTTOUCH ABLATION CATHETER: QTY 1 PERICARDIAL EFFUSION TREATED WITH PERICARDIAL PUNCTURE AND DRAINAGE (CARDIAC TAMPONADE, RECOGNIZED PROCEDURAL COMPLICATION), QTY 1 (PERICARDIAL EFFUSION) TREATED CONSERVATIVELY (MINOR INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738457 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO 3 SYSTEM WITH VISITAG| LASSO MAPPING CATHETER