BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH

    MDR report key: 19601735 · Received June 24, 2024

    Report

    Report Number
    2029046-2024-02056
    Event Type
    Injury
    Date Received
    June 24, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. NO: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FINK T, SCIACCA V, NISCHIK F, BERGAU L, GUCKEL D, EL HAMRITI M, KHALAPH M, BRAUN M, WINNIK S, DIDENKO M, IMNADZE G, SOMMER P, SOHNS C. ATRIAL FIBRILLATION ABLATION WORKFLOW OPTIMIZATION FACILITATED BY HIGH-POWER SHORT-DURATION ABLATION AND HIGH-RESOLUTION MAPPING. EUROPACE. 2024 MAR 1;26(3): EUAE067. DOI: 10.1093/EUROPACE/EUAE067. PMID: 38516791; PMCID: PMC10965399. OBJECTIVE/METHODS/STUDY DATA: AIMS: PULMONARY VEIN ISOLATION (PVI) FOR CATHETER ABLATION OF ATRIAL FIBRILLATION (AF) IS A TIME-DEMANDING PROCEDURE. HIGH-POWER SHORT-DURATION (HPSD) ABLATION PROTOCOLS AND HIGH-DENSITY MAPPING CATHETERS HAVE RECENTLY BEEN INTRODUCED TO CLINICAL PRACTICE. WE INVESTIGATED THE IMPACT OF HIGH-DENSITY MAPPING AND HPSD ABLATION PROTOCOLS ON PROCEDURAL TIMING, EFFICACY, AND SAFETY BY COMPARING DIFFERENT STANDARDIZED SET-UPS. METHODS AND RESULTS: THREE ELECTROPHYSIOLOGY (EP) LABORATORY SET-UPS WERE ANALYSED: (I) CIRCULAR CATHETER FOR MAPPING AND HPSD ABLATION WITH 30/35 W GUIDED BY AN ABLATION INDEX (AI); (II) PENTASPLINE CATHETER FOR MAPPING AN HPSD ABLATION WITH 50 W GUIDED BY AN AI; AND (III) PENTASPLINE CATHETER FOR MAPPING AND HPSD ABLATION WITH 90 W OVER 4 S USING A NOVEL ABLATION CATHETER. ALL PATIENTS UNDERWENT PVI WITHOUT ADDITIONAL LEFT ATRIAL ABLATION STRATEGIES. PROCEDURAL DATA AND OPERATING INTERVALS IN THE EP LABORATORY WERE SYSTEMATICALLY ANALYSED. THREE HUNDRED SEVEN PATIENTS WERE ANALYSED (30/35 W AI: N = 102, 50 W AI: N = 102, 90 W/4 S: N = 103). SKIN-TO-SKIN TIMES [105.3 ± 22.7 (30/35 W AI) VS. 81.4 ± 21.3 (50 W AI) VS. 69.5 ± 12.2 (90 W/4 S) MIN, P = 0.001] AND TOTAL LABORATORY TIMES (132.8 ± 42.1 VS. 107.4 ± 25.7 VS. 95.2 ± 14.0 MIN, P < 0.001) SIGNIFICANTLY DIFFERED AMONG THE STUDY GROUPS. LABORATORY INTERVAL ANALYSIS REVEALED SIGNIFICANT SHORTENING OF MAPPING AND ABLATION TIMES. ARRHYTHMIA-FREE SURVIVAL AFTER 12 MONTHS WAS NOT DIFFERENT AMONG THE STUDY GROUPS (LOG-RANK P = 0.96). CONCLUSION: THE INTEGRATION OF HIGH-DENSITY MAPPING AND HPSD PROTOCOLS INTO AN INSTITUTIONAL AF ABLATION PROCESS RESULTED IN REDUCED PROCEDURE TIMES WITHOUT COMPROMISING SAFETY OR EFFICACY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN VIZIGO CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO 3 SYSTEM, LASSO NAV, THERMOCOOL SMARTTOUCH SF, PENTARAY, QDOT CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BRK-XS NEEDLE (ST. JUDE MEDICAL), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED CARTO VIZIGO SHEATH: QTY 3: FALSE ANEURYSMS (VASCULAR PSEUDOANEURYSM) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT) QTY 2: VENOUS ACCESS SITE BLEEDINGS (BLEEDING) WITH PROLONGED HOSPITAL (PROLONGED HOSPITALIZATION) STAY BUT WITHOUT BLOOD TRANSFUSION (ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480523 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization BRK-XS NEEDLE (ST. JUDE MEDICAL)| CARTO 3 SYSTEM| LASSO NAV| PENTARAY| QDOT| THERMOCOOL SMARTTOUCH SF