BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 19630362 · Received June 27, 2024

    Report

    Report Number
    2029046-2024-02135
    Event Type
    Death
    Date Received
    June 27, 2024
    Date of Event
    February 26, 2024
    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

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TANG RB, LV WH, LONG DY, DONG JZ, DU X, SANG CH, YU RH, HE L, JIANG CX, WEN SN, LIU N, LI SN, WANG W, GUO XY, ZHAO X, LIU XY, WU ZY, LI YK, WANG XS, DU ZH, MA CS. CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH LEFT BUNDLE BRANCH BLOCK. PACING CLIN ELECTROPHYSIOL. 2024 APR;47(4):518-524. DOI: 10.1111/PACE.14954. EPUB 2024 FEB 26. PMID: 38407374. 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: TANG RB, LV WH, LONG DY, DONG JZ, DU X, SANG CH, YU RH, HE L, JIANG CX, WEN SN, LIU N, LI SN, WANG W, GUO XY, ZHAO X, LIU XY, WU ZY, LI YK, WANG XS, DU ZH, MA CS. CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH LEFT BUNDLE BRANCH BLOCK. PACING CLIN ELECTROPHYSIOL. 2024 APR;47(4):518-524. DOI: 10.1111/PACE.14954. EPUB 2024 FEB 26. PMID: 38407374. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: LEFT BUNDLE BRANCH BLOCK (LBBB) AND ATRIAL FIBRILLATION (AF) ARE COMMONLY COEXISTING CONDITIONS. THE IMPACT OF LBBB ON CATHETER ABLATION OF AF HAS NOT BEEN WELL DETERMINED. THIS STUDY AIMS TO EXPLORE THE LONG-TERM OUTCOMES OF PATIENTS WITH AF AND LBBB AFTER CATHETER ABLATION. METHODS: FORTY-TWO PATIENTS WITH LBBB OF 11,752 PATIENTS WHO UNDERWENT CATHETER ABLATION OF AF FROM 2011 TO 2020 WERE ENROLLED AS LBBB GROUP. AFTER PROPENSITY SCORE MATCHING IN A 1:4 RATIO, 168 AF PATIENTS WITHOUT LBBB WERE ENROLLED AS NON-LBBB GROUP. LATE RECURRENCE AND A COMPOSITE ENDPOINT OF STROKE, ALL-CAUSE MORTALITY, AND CARDIOVASCULAR HOSPITALIZATION WERE COMPARED BETWEEN THE TWO GROUPS. RESULTS: LATE RECURRENCE RATE WAS SIGNIFICANTLY HIGHER IN THE LBBB GROUP THAN THAT IN THE NON-LBBB GROUP (54.8% VS. 31.5%, P = .034). MULTIVARIATE ANALYSIS SHOWED THAT LBBB WAS AN INDEPENDENT RISK FACTOR FOR LATE RECURRENCE AFTER CATHETER ABLATION OF AF (HAZARD RATIO [HR] 2.19, 95% CONFIDENCE INTERVAL [CI] 1.09¿4.40, P = .031). LBBB GROUP WAS ALSO ASSOCIATED WITH A SIGNIFICANTLY HIGHER INCIDENCE OF THE COMPOSITE ENDPOINT (21.4% VS. 6.5%, HR 3.98, 95% CI 1.64¿9.64, P = .002). CONCLUSIONS: LBBB WAS ASSOCIATED WITH A HIGHER RISK FOR LATE RECURRENCE AND A HIGHER INCIDENCE OF COMPOSITE ENDPOINT IN THE PATIENTS UNDERWENT CATHETER ABLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL-SMART-TOUCH CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO, NAVI-STAR THERMOCOOL CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A OF NOTE, HERE WAS ONE PATIENT WITH PSEUDOANEURYSM AND TWO PATIENTS WITH INGUINAL HEMATOMAS WHICH WOULD BE ASSOCIATED WITH THE SHEATH, HOWEVER, THE IDENTITY OF THE SHEATH WAS NOT PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL-SMART-TOUCH: QTY 1 CARDIOVASCULAR HOSPITALIZATION (NO INFORMATION AVAILABLE) (PROLONGED HOSPITALIZATION) (ADVERSE EVENT) QTY 1. ALL THE DEATH CASES IN THE TWO GROUPS WERE DUE TO CARDIOVASCULAR CAUSES (NO INFORMATION AVAILABLE) (DEATH) (ADVERSE EVENT-DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819795 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death UNK_CARTO 3| UNK_NAVISTAR THERMOCOOL| UNK_SMART TOUCH UNIDIRECTIONAL