BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_EZ STEER THERMOCOOL SF NAV

    MDR report key: 7175430 · Received January 9, 2018

    Report

    Report Number
    2029046-2018-01005
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 31, 2013
    Report Date
    December 14, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPANY PRODUCTS THAT USED IN THIS STUDY: ENSITE VELOCITY 3-DIMENSIONAL ELECTROANATOMIC SYSTEM (ST JUDE MEDICAL, (B)(4)) AND A MULTIELECTRODE HIGH-DENSITY MAPPING CATHETER (AFOCUS II, ST JUDE MEDICAL) 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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT WITH LONG-STANDING PERSISTENT ATRIAL FIBRILLATION UNDERWENT RADIOFREQUENCY ABLATION AND HAD ACUTE PULMONARY EDEMA WITHIN 48 HOURS OF DISCHARGE. 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: ¿CATHETER ABLATION VS ELECTROPHYSIOLOGICALLY GUIDED THORACOSCOPIC SURGICAL ABLATION IN LONG-STANDING PERSISTENT ATRIAL FIBRILLATION: THE CASA-AF STUDY¿ THE PURPOSE OF THIS STUDY WAS TO COMPARE ELECTROPHYSIOLOGICAL GUIDED THORACOSCOPIC SURGICAL ABLATION WITH PERCUTANEOUS CATHETER ABLATION AS THE FIRST-LINE STRATEGY IN THE TREATMENT OF LONG-STANDING PERSISTENT ATRIAL FIBRILLATION. IN TOTAL 51 PATIENTS WERE ENROLLED BETWEEN JULY 2011 AND DECEMBER 2013. SUSPECT DEVICE IS A 3.5-MM IRRIGATED-TIP THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19778 UNK_EZ STEER THERMOCOOL SF NAV SIMILAR DEVICE BNI35DDCT, PMA # P030031/S025 OAD BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other