BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 11604593 · Received April 1, 2021

    Report

    Report Number
    2029046-2021-00481
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 31, 2020
    Report Date
    March 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE. INTERVENTION WAS NOT REPORTED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THERMOCOOL SMART TOUCH SF. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY, LASSO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BEEAT(JAPAN), LIFELINE (ABBOTT), INQUIRY (ABBOTT). PUBLICATION DETAILS: TITLE: THE EFFECT OF POSTERIOR WALL ISOLATION FOR PERSISTENT ATRIAL FIBRILLATION ON RECURRENT ARRHYTHMIA. OBJECTIVE: IT IS IMPORTANT TO CONSIDER RECURRENT ARRHYTHMIA AFTER CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION (AF) FOR PLANNING AN ABLATION STRATEGY. HOWEVER, THE STUDIES ARE LIMITED TO PULMONARY VEIN ISOLATION (PVI) PLUS POSTERIOR WALL ISOLATION (PWI), WHICH WERE REPORTED TO IMPROVE PROCEDURAL OUTCOMES. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE EFFECT OF PWI ON RECURRENT ARRHYTHMIA. METHODS: THIS IS AN OBSERVATIONAL STUDY ON PATIENTS WITH PERSISTENT AF COMPARING PVI PLUS PWI AND PVI ONLY STRATEGIES. IN PVI PLUS PWI GROUP, LINEAR ABLATION OF THE LEFT ATRIUM ROOFLINE AND BOTTOM LINE WERE PERFORMED TO ACHIEVE PWI AFTER PVI. SOME PATIENTS WITH AF RECURRENCE UNDERWENT THE SECOND PROCEDURE. THE PRESENCE OF RECURRENT ARRHYTHMIA AND RESULTS OF THE SECOND PROCEDURES WERE EVALUATED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBER: 2029046-2021-00480 IS RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE. INTERVENTION WAS NOT REPORTED. WHILE LITERATURE SOURCE IS A VALUABLE SOURCE OF INFORMATION; HOWEVER, IT HAS LIMITATIONS, INCLUDING NONSPECIFIC AND VERY LIMITED INFORMATION ABOUT EACH REPORTABLE EVENT. DUE TO MISSING DATA, IT IS NOT POSSIBLE TO BE CONFIDENT OF THE DISTRIBUTION OF PATIENTS WITH COMPLICATIONS USING BWI DEVICES IN THIS PUBLICATION. IN THIS PUBLICATION, IT WAS REPORTED THAT EITHER THE THERMOCOOL SMART TOUCH OR THERMOCOOL SMART TOUCH SF WAS USED. AS SUCH CERENOVUS IS USING A PROPORTIONAL APPROACH TO ESTIMATE NUMBER OF PATIENTS EXPERIENCING COMPLICATIONS. THEREFORE, WE WILL ASSIGN ONE ADVERSE EVENT TO EACH DEVICE. THEREFORE: THERMOCOOL SMART TOUCH : PULMONARY VEIN STENOSIS OR THERMOCOOL SMART TOUCH SF: CARDIAC TAMPONADE MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THERMOCOOL SMART TOUCH OR THERMOCOOL SMART TOUCH SF. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY, LASSO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BEEAT(JAPAN), LIFELINE (ABBOTT), INQUIRY (ABBOTT). PUBLICATION DETAILS. TITLE: THE EFFECT OF POSTERIOR WALL ISOLATION FOR PERSISTENT ATRIAL FIBRILLATION ON RECURRENT ARRHYTHMIA. OBJECTIVE: IT IS IMPORTANT TO CONSIDER RECURRENT ARRHYTHMIA AFTER CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION (AF) FOR PLANNING AN ABLATION STRATEGY. HOWEVER, THE STUDIES ARE LIMITED TO PULMONARY VEIN ISOLATION (PVI) PLUS POSTERIOR WALL ISOLATION (PWI), WHICH WERE REPORTED TO IMPROVE PROCEDURAL OUTCOMES. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE EFFECT OF PWI ON RECURRENT ARRHYTHMIA. METHODS: THIS IS AN OBSERVATIONAL STUDY ON PATIENTS WITH PERSISTENT AF COMPARING PVI PLUS PWI AND PVI ONLY STRATEGIES. IN PVI PLUS PWI GROUP, LINEAR ABLATION OF THE LEFT ATRIUM ROOFLINE AND BOTTOM LINE WERE PERFORMED TO ACHIEVE PWI AFTER PVI. SOME PATIENTS WITH AF RECURRENCE UNDERWENT THE SECOND PROCEDURE. THE PRESENCE OF RECURRENT ARRHYTHMIA AND RESULTS OF THE SECOND PROCEDURES WERE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498833 UNK_SMART TOUCH BIDIRECTIONAL SF UNK LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening BEEAT (JAPAN)| INQUIRY (ABBOTT)| LIFELINE (ABBOTT)| UNK_LASSO| UNK_PENTARAY NAV| BEEAT (JAPAN)| INQUIRY (ABBOTT)| LIFELINE (ABBOTT)| UNK_LASSO| UNK_PENTARAY NAV