BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 12602200 · Received October 9, 2021

    Report

    Report Number
    2029046-2021-01711
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    August 5, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). KAWAJI, T, AIZAWA, T, HOJO, S, KUSHIYAMA, A, YAKU, H, NAKATSUMA, K, ET AL. THE IMPACT OF CURRENT STRATEGY USING INTRACARDIAC ECHOCARDIOGRAPHY, LESION INDEX, AND MINIMUM SUBSTRATE ABLATION ON CLINICAL OUTCOMES AFTER CATHETER ABLATION PROCEDURE FOR ATRIAL FIBRILLATION. J ARRHYTHMIA. 2021; 37: 1278¿ 1286. HTTPS://DOI.ORG/10.1002/JOA3.12611 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. 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 · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KAWAJI, T, AIZAWA, T, HOJO, S, KUSHIYAMA, A, YAKU, H, NAKATSUMA, K, ET AL. THE IMPACT OF CURRENT STRATEGY USING INTRACARDIAC ECHOCARDIOGRAPHY, LESION INDEX, AND MINIMUM SUBSTRATE ABLATION ON CLINICAL OUTCOMES AFTER CATHETER ABLATION PROCEDURE FOR ATRIAL FIBRILLATION. J ARRHYTHMIA. 2021; 37: 1278¿ 1286. HTTPS://DOI.ORG/10.1002/JOA3.12611 OBJECTIVE: THE AUTHORS DEVELOPED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TECHNIQUE TO MINIMIZE RADIATION EXPOSURE AND OTHER RECENT TECHNOLOGY DURING ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AF). THE AIM OF THIS STUDY WAS TO VALIDATE THE IMPACT OF THE CURRENT STRATEGY USING THE RECENT TECHNOLOGY FOR AF ABLATION ON OUTCOMES AFTER PROCEDURE. METHODS/STUDY DATA: A TOTAL OF 456 ABLATION PROCEDURES IN PATIENTS CONSECUTIVE AF PATIENTS UNDERGOING FIRST-TIME CATHETER ABLATION PROCEDURE IN A SINGLE INSTITUTION BETWEEN APRIL 2017 AND JUNE 2020. MEAN AGE WAS 70 YEARS OLD AND THE PREVALENCE OF FEMALE WAS ABOUT 30%. THE CURRENT STRATEGY INCLUDED THE TECHNIQUE OF ICE TO REDUCE RADIATION EXPOSURE, ABLATION INDEX®-GUIDED PULMONARY VEINS ISOLATION, AND MINIMUM SUBSTRATE ABLATION TARGETING ONLY FOR INDUCED AF. OUTCOME MEASURES WERE RADIATION EXPOSURE, PROCEDURE TIME, IN-HOSPITAL ADVERSE OUTCOMES, AND EVENT-FREE SURVIVAL FROM TACHYARRHYTHMIAS. THE MAIN FINDINGS OF THIS STUDY EVALUATING THE SAFETY AND EFFICACY OF THE CURRENT STRATEGY USING THE TECHNIQUE WITH CARTO SOUND®, ABLATION INDEX®-GUIDED PVI, AND MINIMUM SUBSTRATE ABLATION IN ADDITION TO PVI DURING CATHETER ABLATION FOR AF WERE THE FOLLOWINGS; (1) PUNCTURE-TO-ABLATION TIME WAS SLIGHTLY INCREASED IN THE CURRENT STRATEGY, BUT TOTAL PROCEDURE TIME WAS DECREASED; (2) THE CURRENT STRATEGY REDUCED MAJORITY OF RADIATION EXPOSURE; (3) THE INCIDENCE OF IN-HOSPITAL ADVERSE OUTCOMES AND EVENT-FREE SURVIVAL FROM RECURRENT ATRIAL TACHYARRHYTHMIAS WERE ALMOST UNCHANGED. OF NOTE: THE AUTHORS USED ABLATION CATHETERS FROM 2 DIFFERENT MANUFACTURERS BUT DID NOT PROVIDE INFORMATION TO ASSOCIATE THE FOLLOWING ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS. THE ACTUAL NUMBER OF BWI DEVICES ASSOCIATED WITH THESE EVENTS IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL ST ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3D SYSTEM. VISITAG. PENTARAY 2-6.2 MM 20-POLAR MAPPING CATHETER. FAM (FAST ANATOMICAL MAPPING) BIPOLAR VOLTAGE MAP. CARTO SOUNDSTAR . NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: FANTASIA 8-MM ABLATION CATHETER (JAPAN LIFELINE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 3 CARDIAC TAMPONADE TREATED WITH PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500346 UNK_SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R