BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 6734920 · Received July 23, 2017

    Report

    Report Number
    9673241-2017-00597
    Event Type
    Injury
    Date Received
    July 23, 2017
    Date of Event
    April 30, 2015
    Report Date
    July 5, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO RMT. OTHER COMPANIES DEVICES THAT USED IN THIS STUDY: NIOBE ES, RMN NIOBE II, STEERABLE CATHETER (INQUIRY, ST. JUDE MEDICAL, INC.) AND A FLEXIBLE QUADRIPOLAR CATHETER (MEDTRONIC, INC.). (B)(4). THE DEVICE IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 726 PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) AND PERSISTENT AF (PERAF) UNDERWENT CATHETER ABLATION GUIDE BY REMOTE MAGNETIC NAVIGATION FROM JANUARY 2009 AND APRIL 2015. AMONG THEM, ONE PATIENT HAD CARDIAC TAMPONADE DURING THE TRANSSEPTAL PUNCTURE IN PAF GROUP. PERICARDIOCENTESIS AND DRAINAGE WERE PERFORMED, AND DRAINAGE CATHETERS WERE REMOVED 24 HOURS AFTER ECHOCARDIOGRAPHY CONFIRMED THE ABSENCE OF INTRAPERICARDIAL BLEEDING. 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: ¿EFFICACY AND SAFETY OF ATRIAL FIBRILLATION ABLATION USING REMOTE MAGNETIC NAVIGATION: EXPERIENCE FROM 1,006 PROCEDURES.¿ THE PURPOSE OF THIS STUDY WAS TO ASSESS THE PROCEDURAL OUTCOMES OF CATHETER ABLATION GUIDED BY REMOTE MAGNETIC NAVIGATION (RMN) IN A LARGE COHORT OF PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) AND PERSISTENT AF (PERAF). SUSPECT DEVICE IS A NAVISTAR THERMOCOOL RMT CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515283 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE NR7TCSIY, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1266-00 UNKNOWN_D-1266-00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R