BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR RMT THERMOCOOL

    MDR report key: 14640871 · Received June 9, 2022

    Report

    Report Number
    2029046-2022-01238
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    December 26, 2021
    Report Date
    June 8, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BENALI K, HAMMACHE N, SELLAL JM, MAZEN E, DE CHILLOU C. CATHETER KNOT AROUND THE MITRAL VALVE APPARATUS: AN EXCEPTIONAL COMPLICATION OF REMOTE MAGNETIC NAVIGATION. J CARDIOVASC ELECTROPHYSIOL. 2022 JAN;33(1):137-139. DOI: 10.1111/JCE.15313. EPUB 2021 DEC 16. PMID: 34897865. THE LITERATURE ARTICLE IS TOO LARGE TO ATTACH. 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. MANUFACTURER¿S REFERENCE NUMBER: PC-(B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BENALI K, HAMMACHE N, SELLAL JM, MAZEN E, DE CHILLOU C. CATHETER KNOT AROUND THE MITRAL VALVE APPARATUS: AN EXCEPTIONAL COMPLICATION OF REMOTE MAGNETIC NAVIGATION. J CARDIOVASC ELECTROPHYSIOL. 2022 JAN;33(1):137-139. DOI: 10.1111/JCE.15313. EPUB 2021 DEC 16. PMID: 34897865. OBJECTIVE/METHODS/STUDY DATA: REMOTE MAGNETIC NAVIGATION (RMN) IS AS SAFE AND EFFECTIVE AS MANUAL NAVIGATION FOR CATHETER ABLATION OF VENTRICULAR ARRHYTHMIAS. THIS CASE IS THE FIRST DESCRIPTION OF A SOFT-TIP ABLATION CATHETER ENTRAPMENT IN THE MITRAL VALVE APPARATUS DURING AN RMN ABLATION PROCEDURE. THE TIGHT KNOT CREATED BY THE CATHETER AROUND A MITRAL VALVE CHORDAE REQUIRED SURGICAL REMOVAL. THIS COMPLICATION, WHICH HAS NEVER BEEN REPORTED BEFORE, HIGHLIGHTS THE NEED FOR CLOSER FLUOROSCOPIC MONITORING WHEN PERFORMING CATHETER LOOPS INSIDE THE VENTRICLES WHEN USING THE RMN SYSTEM LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTAR THERMOCOOL RMT; BIOSENSE WEBSTER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: -CARTO SYSTEM (BIOSENSE WEBSTER INC.). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEREOTAXIS REMOTE MAGNETIC NAVIGATION (RMN). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: FLUOROSCOPY IMAGES REVEALED THAT THE TIP OF THE ABLATION CATHETER WAS ENTRAPPED WITHIN THE MITRAL VALVE APPARATUS, APPEARING TO MAKE A KNOT AROUND A MITRAL CHORDAE TENDINEAE. THE PROBABLE MECHANISM AT THE ORIGIN OF THE KNOT FORMATION . GENTLE TRACTION ON THE CATHETER AND MANUAL CLOCKWISE AND COUNTERWISE ROTATIONS WERE ATTEMPTED BUT FAILED TO UNTIE THE KNOT. THE PATIENT REQUIRED CARDIAC SURGERY TO REMOVE THE CATHETER. THE CATHETER WAS SUCCESSFULLY CUT AND REMOVED FROM THE MITRAL VALVE APPARATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894653 UNK_NAVISTAR RMT THERMOCOOL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO SYSTEM (BIOSENSE WEBSTER INC.)| STEREOTAXIS REMOTE MAGNETIC NAVIGATION (RMN)