BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 11791775 · Received May 7, 2021

    Report

    Report Number
    2029046-2021-00728
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    October 29, 2019
    Report Date
    April 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 1 PATIENT UNDERWENT CATHETER ABLATION OF SCAR RELATED VENTRICULAR TACHYCARDIA AND SUFFERED PERICARDIAL TAMPONADE. INTERVENTION WAS NOT REPORTED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS SMARTTOUCH® SF ABLATION CATHETER F-J CURVE, BIOSENSE WEBSTER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS: TITLE: IMAGE-GUIDED ABLATION OF SCAR-RELATED VENTRICULAR TACHYCARDIA: TOWARDS A SHORTER AND MORE PREDICTABLE PROCEDURE. OBJECTIVE: THE AIM OF THIS STUDY WAS TO ANALYZE THE FEASIBILITY AND REPRODUCIBILITY OF USING IMAGE INTEGRATION SOFTWARE AT A REMOTE SETTING OVER THE MUSIC NETWORK TO PERFORM IMAGE-GUIDED VT ABLATION. FURTHERMORE, WE ANALYZED THE EFFICACY OF A FOCUSED WORKFLOW WITH ELECTROANATOMICAL MAPPING (EAM) LIMITED TO IMAGING-DEFINED SCAR. METHODS: IN A PROSPECTIVE TWO-CENTRE STUDY, CONSECUTIVE PATIENTS UNDERGOING IMAGE INTEGRATION-GUIDED VT ABLATION (MAGNETIC RESONANCE [DE-MRI] AND/OR MULTIDETECTOR COMPUTED TOMOGRAPHY [MDCT]) WERE INCLUDED. PATIENTS WERE DIVIDED INTO TWO GROUPS (GROUP 1, COMPLETE EAM; GROUP 2, EAM LIMITED TO IMAGING-DEFINED SUBSTRATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685819 UNK_SMART TOUCH BIDIRECTIONAL SF UNK LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening