BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR RMT 4MM

    MDR report key: 7077210 · Received December 1, 2017

    Report

    Report Number
    2029046-2017-01221
    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
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 (PATIENT #23) WITH SCAR-RELATED VENTRICULAR TACHYCARDIA (VT) UNDERWENT RADIOFREQUENCY ABLATION AND DEVELOPED UNCOMPLICATED BILATERAL LOWER-EXTREMITY DEEP VENOUS THROMBOSIS THAT WAS SUCCESSFULLY TREATED WITH ANTICOAGULATION. PATIENT'S MEDICAL HISTORY INCLUDES INCESSANT MONOMORPHIC VT, ICD STORM. 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 DEVICES ARE REMOTELY GUIDED, 4-MM-TIP, NAVISTAR QUADRIPOLAR (RMT) CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853212 NAVISTAR RMT 4MM SIMILAR DEVICE NR7TCSIY, PMA # P030031 DRF BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR