BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 3994439 · Received August 8, 2014

    Report

    Report Number
    2029046-2014-00243
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 1, 2010
    Report Date
    July 23, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ARTICLE TITLE: PERIPROCEDURAL STROKE RISK IN PATIENTS UNDERGOING CATHETER ABLATION FOR ATRIAL FIBRILLATION ON UNINTERRUPTED WARFARIN. PER A REPORT IN THE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY VOL. 25, NO. 6, JUNE 2014 A CONTROLLED, MULTICENTER, RETROSPECTIVE STUDY WAS CONDUCTED ON 2855 PATIENTS, (B)(6)., WAS CONDUCTED TO COMPARE THE INCIDENCE, SEVERITY AND TIMING OF PERIPROCEDURAL STROKE BETWEEN 2 PERIPROCEDURAL ANTICOAGULATION PROTOCOLS: BRIDGING LOW-MOLECULAR-WEIGHT HEPARIN (LMWH) AND UNINTERRUPTED WARFARIN (UW) THIS REPORT COVERS PATIENT #8 OF THE ARTICLE. THE (B)(6), WITH A LONG STANDING HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT RADIOFREQUENCY (RF) ABLATION. THE PATIENT¿S LEFT VENTRICULAR EJECTION FRACTION WAS 55%. THE MEAN CHADS2 SCORE WAS 0 AND MEAN ACT WAS 356. THE CATHETER ABLATION WAS PERFORMED USING A BRIDGING LMWH PROTOCOL. THE PATIENT STOPPED WARFARIN 5 DAYS PRIOR TO THE PROCEDURE WITH BRIDGING SELF-ADMINISTERED SUBCUTANEOUS INJECTIONS OF LMWH (ENOXAPARIN 1.5 MG/KG ONCE DAILY). THE PATIENT EXPERIENCED A TOTAL ANTERIOR CIRCULATION STROKE ASSOCIATED WITH HEMIPLEGIA, HEMIANOPIA, DYSPHASIA WITHIN 12 HOURS POSTOP. SUBSEQUENTLY THE PATIENT FULLY RECOVERED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. CONCOMITANT PRODUCTS: CARTO MAPPING SYSTEM. OTHER NON BWI DEVICES WERE USED DURING CARDIAC ABLATION: A PULMONARY VEIN MAPPING CATHETER ((B)(6)) AND ROBOTICALLY ASSISTED CATHETER MANIPULATION ((B)(6))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471013 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR THERMOCOOL UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R