BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL

    MDR report key: 7077205 · Received December 1, 2017

    Report

    Report Number
    2029046-2017-01220
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 31, 2006
    Report Date
    November 15, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. OTHER COMPANIES DEVICES THAT USED IN THIS STUDY: NIOBE STEREOTAXIS MNS (STEREOTAXIS, INC, (B)(4)). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE (B)(6) PATIENT WITH SCAR-RELATED VENTRICULAR TACHYCARDIA (VT) AND PRIOR CARDIAC SURGERY UNDERWENT PERICARDIAL MAPPING WITH THE MANUAL CATHETER AND DEVELOPED A LOCULATED PERICARDIAL EFFUSION IN THE POSTERIOR ASPECT OF THE LEFT ATRIUM WITH PARTIAL COMPRESSION REQUIRING SURGICAL PERICARDIAL DECOMPRESSION. PATIENT'S MEDICAL HISTORY INCLUDES SUSTAINED MONOMORPHIC VT, ICD STORM, PRIOR FAILED RADIO-FREQUENCY ABLATION. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿REMOTE MAGNETIC NAVIGATION TO GUIDE ENDOCARDIAL AND EPICARDIAL CATHETER MAPPING OF SCAR-RELATED VENTRICULAR TACHYCARDIA¿ THE PURPOSE OF THIS STUDY TO EXAMINE THE SAFETY AND FEASIBILITY OF USING A REMOTE MAGNETIC NAVIGATION SYSTEM TO PERFORM ENDOCARDIAL AND EPICARDIAL SUBSTRATE-BASED MAPPING AND RADIOFREQUENCY ABLATION IN PATIENTS WITH SCAR-RELATED VENTRICULAR TACHYCARDIA. THE STUDY WAS CONDUCTED BETWEEN NOVEMBER 2005 AND OCTOBER 2006. SUSPECT DEVICE IS EXTERNALLY IRRIGATED, 3.5-MM-TIP THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853209 SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R