BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC-EZ STEER TCOOL NONNAV THR

    MDR report key: 5097632 · Received September 23, 2015

    Report

    Report Number
    9673241-2015-00666
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    February 28, 2011
    Report Date
    September 8, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 MAPPING SYSTEM OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: CONVENTIONAL TRANSTHORACIC ECHOCARDIOGRAPHIC EVALUATIONS (VIVID 9, GE VINGMED ULTRASOUND, (B)(4) OR SONOS 5500, PHILIPS MEDICAL SYSTEMS), COMPUTED TOMOGRAPHY (CT) (SOMATOM DEFINITION FLASH, SIEMENS HEALTHCARE), NAVX (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 NONVALVULAR ATRIAL FIBRILLATION UNDER RADIOFREQUENCY CATHETER ABLATION. THE PATIENT SUFFERED CARDIAC TAMPONADE WHICH WAS TREATED WITH PERICARDIOCENTESIS. 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: "PROGNOSTIC IMPLICATIONS OF RIGHT AND LEFT ATRIAL ENLARGEMENT AFTER RADIOFREQUENCY CATHETER ABLATION IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION." THE PURPOSE OF THIS STUDY WAS TO ASSESS STRUCTURAL CHANGES IN RIGHT ATRIUM AND LEFT ATRIUM AND DETERMINE THEIR ASSOCIATION WITH RECURRENCE OF AF AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA). THE STUDY WAS CONDUCTED BETWEEN 2009 AND 2011. SUSPECT DEVICE IS A 3.5-MM IRRIGATED-TIP THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER SERIOUS AND NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE (SERIOUS EVENTS ARE REPORTED TO FDA SEPARATELY): 1 PATEINT STROKE. 5 PATIENTS HEMATOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629434 GENERIC-EZ STEER TCOOL NONNAV THR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1295-00 UNKNOWN_EZ_STEER_TC_NNAV

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R