BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 10628070 · Received October 5, 2020

    Report

    Report Number
    2029046-2020-01393
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). 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 COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT (B)(6) PATIENT UNDERWENT PULMONARY VEIN ISOLATION AND SUFFERED CARDIAC TAMPONADE. INTERVENTION WAS NOT REPORTED. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BWI ULTRASOUND PROBE, LASSO, PENTARAY, CARTO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8-F ACUNAV. PUBLICATION DETAILS, TITLE: IMPEDANCE MAPPING WITH CONSTANT CONTACT FORCE ON 3D ELECTROANATOMIC MAP TO CHARACTERIZE TISSUES AT PULMONARY VENO-ATRIAL JUNCTION. OBJECTIVE: ENERATOR IMPEDANCE (IM) MAPPING WITH CONSTANT CONTACT FORCE (CF) BY TIP CATHETER AT PV ISOLATION (PVI) WAS ASSESSED FOR A PROPOSAL OF TISSUE CHARACTERIZATION AT PV-LA JUNCTION (PV-LAJ). METHODS: IN THIS OBSERVATIONAL, PROSPECTIVE, SINGLE-CENTER STUDY, IM MAPPING AT CONSTANT CF = 10 G (± 2 G) WAS PERFORMED BEFORE PVI AT PV-LAJ. PV IN-VEIN, PV OSTIUM (PVOS), AND ANTRUM (PVAN) CONTOURS WERE MANUALLY TRACED BASED ON THE 3D ELECTROANATOMIC MAP (3DEAM) INTEGRATING INTRACARDIAC ECHOCARDIOGRAPHY AND COMPUTERIZED TOMOGRAPHY. PVAN CONTOUR-METHODS BASED ON IM MAPPING WAS DEFINED ON 3DEAM AS THE ATRIAL-LIKE IM CONTOUR CLOSEST TO PVOS, AND ITS D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096567 UNK_SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening