BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 14676650 · Received June 13, 2022

    Report

    Report Number
    2029046-2022-01283
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    January 3, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: JANKELSON L, GARBER L, SHULMAN E, COHEN RB, PETERSON C, WADHWANI L, NADEAU-ROUTHIER C, XIA Y, BARBHAIYA C, HOLMES D, KNOTTS R, BERNSTEIN S, KUSHNIR A, SPINELLI M, PARK D, AIZER A, CHINITZ L. OUTCOMES OF POSTERIOR WALL ISOLATION WITH PULMONARY VEIN ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 FEB;33(2):209-217. DOI: 10.1111/JCE.15325. EPUB 2022 JAN 3. PMID: 34911157. THE LITERATURE FILE IS TOO LARGE TO ATTACH. 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. 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: JANKELSON L, GARBER L, SHULMAN E, COHEN RB, PETERSON C, WADHWANI L, NADEAU-ROUTHIER C, XIA Y, BARBHAIYA C, HOLMES D, KNOTTS R, BERNSTEIN S, KUSHNIR A, SPINELLI M, PARK D, AIZER A, CHINITZ L. OUTCOMES OF POSTERIOR WALL ISOLATION WITH PULMONARY VEIN ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 FEB;33(2):209-217. DOI: 10.1111/JCE.15325. EPUB 2022 JAN 3. PMID: 34911157. OBJECTIVE/METHODS/STUDY DATA: -INTRODUCTION: PRIOR STUDIES HAVE SHOWN THAT ADDITION OF POSTERIOR WALL ISOLATION (PWI) MAY REDUCE ATRIAL FIBRILLATION RECURRENCE IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION. NO DATA ON PWI IN PAROXYSMAL AF (PAF) PATIENTS WITH NORMAL LEFT ATRIAL VOLTAGE IS AVAILABLE, TO DATE. -OBJECTIVE: THIS STUDY SOUGHT TO EVALUATE THE EFFICACY OF PWI IN ADDITION TO PULMONARY VEIN ISOLATION (PVI) IN PATIENTS PRESENTING WITH PAF AND NORMAL LEFT ATRIAL VOLTAGE. - METHODS: CONSECUTIVE PATIENT REGISTRY ANALYSIS WAS PERFORMED ON ALL PATIENTS WITH PAF AND NORMAL LEFT ATRIAL VOLTAGE UNDERGOING INITIAL RADIOFREQUENCY ABLATION FROM NOVEMBER 1, 2018 TO NOVEMBER 15, 2019. PRIMARY ENDPOINT WAS RECURRENCE OF ATRIAL ARRHYTHMIA INCLUDING AF, ATRIAL TACHYCARDIA (AT), OR ATRIAL FLUTTER (AFL). -RESULTS: A TOTAL OF 321 PATIENTS WERE STUDIED, 214 IN THE PVI GROUP AND 107 IN THE PWI + PVI GROUP. RECURRENCE OF ANY ATRIAL ARRHYTHMIA OCCURRED IN 18.2% OF PATIENTS IN THE PVI GROUP AND 16.8% IN THE PVI + PWI COHORT (P = 0.58). AT 1 YEAR, RECURRENCE WAS 14.0% IN THE PVI GROUP AND 15.0% IN THE PWI + PVI GROUP (P = 0.96). THERE WAS A LOWER AT/AFL RECURRENCE IN THE PVI + PWI GROUP, NOT REACHING SIGNIFICANCE (3.7% IN THE PWI + PVI GROUP VS. 7.9% IN PVI GROUP, P = 0.31). NEED FOR CARINA LESIONS PREDICTED RECURRENCE IN THE PVI-ONLY GROUP. -CONCLUSIONS: ADDITION OF PWI TO PVI IN PAF PATIENTS UNDERGOING THEIR FIRST ABLATION DID NOT REDUCE THE FREQUENCY OF ATRIAL ARRHYTHMIA RECURRENCE. THIS WARRANTS FURTHER STUDY IN A PROSPECTIVE TRIAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: -THERMOCOOL SMARTTOUCH, OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: -CARTO 3 -PENTARAY -LASSO, BIOSENSE WEBSTER NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: - ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, SMITHS MEDICAL ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: -1 PATIENT SUFFERED OCCURRENCE OF A PERICARDIAL EFFUSION ULTIMATELY REQUIRING PERICARDIOCENTESIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990470 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R ACOUSTASCOPE ESOPHAGEAL STETHOSCOPEL| CARTO 3| LASSO, BIOSENSE WEBSTER| PENTARAY| THERMOCOOL SMARTTOUCH