BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 5118234 · Received October 1, 2015

    Report

    Report Number
    9673241-2015-00696
    Event Type
    Injury
    Date Received
    October 1, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: LASSO CIRCULAR MAPPING CATHETER, CARTO RMT SYSTEM, NIOBE ES (STEREOTAXIS INC), CATHETER-ADVANCING SYSTEM (CARDIODRIVE) OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: STEERABLE CATHETER (INQUIRY, ST. JUDE MEDICAL), SL0 SHEATH (ST. JUDE MEDICAL). (B)(4). METHODS: NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT WITH PERSISTENT ATRIAL FIBRILLATION UNDERWENT CATHETER ABLATION AND EXPERIENCED POSTPROCEDURAL TRANSIENT ST ELEVATION POSSIBLY DUE TO AN AIR EMBOLISM. THE PHYSICIAN STATED THAT BWI DEVICE DID NOT LED TO THE REPORTED COMPLICATION. THE PHYSICIAN ALSO STATED THAT COMPLICATION WAS RELATED TO PV ANGIOGRAPHY AND POSSIBLY DEVICE-RELATED, HOWEVER NO BWI DEVICE MALFUNCTIONS WERE REPORTED. THE COMPLICATION DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE PATIENT WAS FULLY RECOVERED. TITLE: "IMPACT OF CATHETER ABLATION WITH REMOTE MAGNETIC NAVIGATION ON PROCEDURAL OUTCOMES IN PATIENTS WITH PERSISTENT AND LONG-STANDING PERSISTENT ATRIAL FIBRILLATION." THE PURPOSE OF THIS STUDY WAS TO ASSESS THE PROCEDURAL OUTCOMES OF PERSISTENT AND LONG-STANDING PERSISTENT ATRIAL FIBRILLATION (PSAF AND L-PSAF) ABLATION GUIDED BY REMOTE MAGNETIC NAVIGATION (RMN), AND TO DETECT FACTORS PREDICTING ACUTE RESTORATION OF SINUS RHYTHM (SR) BY ABLATION WITH RMN. THE STUDY WAS CONDUCTED BETWEEN JANUARY 2008 AND NOVEMBER 2013. SUSPECT DEVICE IS NAVISTAR THERMOCOOL RMT ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE: 2 PATIENTS HEMATOMA. THE AWARENESS DATE FOR THIS COMPLAINT IS 09/10/2015 BECAUSE THE ARTICLE WAS REVIEWED ON 09/10/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650072 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 59 YR Life Threatening