BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4839661 · Received June 11, 2015

    Report

    Report Number
    2029046-2015-00159
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    June 30, 2012
    Report Date
    May 21, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 USED DURING THIS CLINICAL STUDY: CARTO MAPPING SYSTEM. OTHER COMPANY¿S DEVICES USED DURING THIS CLINICAL STUDY: 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER (ACUNAV, SIEMENS MEDICAL), NAVX (ST. JUDE MEDICAL), 4FR DECAPOLAR CATHETER (ST. JUDE MEDICAL). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED ONE CASE OF PERICARDIAL EFFUSION IN ONE PATIENT WITH EARLIEST ACTIVATION IN THE ANTERIOR INTERVENTRICULAR VEIN, PRESUMED SECONDARY TO CORONARY SINUS PERFORATION WHILE MAPPING AS NO ABLATION WAS DELIVERED WITHIN THE CORONARY VENOUS SYSTEM. THIS PATIENT UNDERWENT PERICARDIOCENTESIS TO DRAIN THE EFFUSION WITHOUT RECURRENCE. THERE WERE NO SIGNS OR SYMPTOMS OF ACUTE ISCHEMIA, INCLUDING ST- SEGMENT CHANGES ON ECG OR WALL-MOTION ABNORMALITY BY INTRACARDIAC ECHOCARDIOGRAPHY IN ANY PATIENTS. TITLE: ¿VENTRICULAR ARRHYTHMIAS FROM THE CORONARY VENOUS SYSTEM: PREVALENCE, MAPPING, AND ABLATION.¿ THE PURPOSE OF THIS STUDY WAS TO IDENTIFY THE PREVALENCE AND EFFECTIVE MAPPING/ABLATION STRATEGIES FOR IDIOPATHIC VENTRICULAR ARRHYTHMIAS MAPPED TO THE CORONARY VENOUS SYSTEM. THE STUDY WAS CONDUCTED BETWEEN (B)(6) 2007 AND (B)(6) 2012. 47 PATIENTS WITH FREQUENT SYMPTOMATIC VENTRICULAR PREMATURE DEPOLARIZATIONS (VENTRICULAR PREMATURE DEPOLARIZATIONS; >7500 PER 24 HOURS) OR SUSTAINED VENTRICULAR ARRHYTHMIAS WITH SITE OF EARLIEST ACTIVATION INSIDE THE BRANCHES OF THE CORONARY SINUS AFTER DETAILED ACTIVATION MAPPING OF THE ADJACENT ENDOCARDIUM OF THE RIGHT VENTRICLE AND LEFT VENTRICLE AS WELL AS THE AORTIC SINUSES OF VALSALVA WERE RETROSPECTIVELY ANALYZED. OTHER ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE: ONE PATIENT VASCULAR PSEUDOANEURYSM; ONE PATIENT CORONARY ARTERY STENOSIS. SUSPECTED DEVICE IS THERMOCOOL, HOWEVER, CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER BWI PRODUCTS WERE USED DURING THIS CLINICAL TRIAL: CARTO MAPPING SYSTEM. OTHER COMPANY¿S DEVICES: 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER (ACUNAV, SIEMENS MEDICAL), NAVX (ST. JUDE MEDICAL), 4FR DECAPOLAR CATHETER (ST. JUDE MEDICAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381486 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R