BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE BNI75TCDDH, PMA # P030031

    MDR report key: 6909279 · Received October 2, 2017

    Report

    Report Number
    9673241-2017-01130
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 8, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. CONCOMITANT PRODUCTS THAT WERE USED IN THIS STUDY: LASSO. OTHER COMPANIES DEVICES THAT USED IN THIS STUDY: ENSITE NAVX, INQUIRY TM. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 246 PATIENTS WITH ATRIAL FIBRILLATION DISEASE UNDERWENT RADIOFREQUENCY CATHETER ABLATION DEXMEDETOMIDINE-BASED CONTINUOUS DEEP SEDATION. AMONG THEM, 1 PATIENT DEVELOPED A PHRENIC NERVE INJURY; THE SYMPTOM OF DYSPNEA IMPROVED WITHIN 6 MONTHS, BUT THE DIAPHRAGMATIC FUNCTION WAS NOT COMPLETELY RECOVERED. 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: ¿AIRWAY SUPPORT USING A PEDIATRIC INTUBATION TUBE IN ADULT PATIENTS WITH ATRIAL FIBRILLATION: A SIMPLE AND UNIQUE METHOD TO PREVENT HEART MOVEMENT DURING CATHETER ABLATION UNDER CONTINOUS DEEP SEDATION. THE PURPOSE OF THIS STUDY WAS TO PREVENT HEART MOVEMENT DURING CATHETER ABLATION UNDER CONTINOUS DEEP SEDATION. RF ENERGY WAS DELIVERED WITH A NON-IRRIGATED 8-MM-TIP ABLATION CATHETER (JAPAN LIFELINE) OR AN IRRIGATED 4-MM-TIP ABLATION CATHETER (COOLPATHDUO, ST.JUDE MEDICAL OR EZ STEER THERMOCOOL NAV). IT IS UNKNOWN WHICH DEVICES THE PATIENTS WHO SUFFERED COMPLICATIONS HAVE USED. BWI TAKES CONSERVATIVE APPROACH TO REPORT ALL THE EVENTS OCCURRED UNDER EZ STEER THERMOCOOL NAV, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687825 SIMILAR DEVICE BNI75TCDDH, PMA # P030031 SIMILAR DEVICE BNI75TCDDH, PMA # P030031 LPB BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other