BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4288376 · Received December 1, 2014

    Report

    Report Number
    2029046-2014-00450
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    December 1, 2014
    Report Date
    November 13, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER PMA # P030031. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: LASSO CATHETER; US CATALOG #: UNKNOWN; LOT #: UNKNOWN. PRODUCT NAME: CARTO; US CATALOG #: UNKNOWN; SERIAL #: UNKNOWN. NON-BWI PRODUCTS USED: THERAPY COOLPATH; ST. JUDE MEDICAL, INQUIRY OPTIMA OR REFLEXION SPIRAL; ST. JUDE MEDICAL, ENSITE VELOCITY NAVX; ST. JUDE MEDICAL INC. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM THE LITERATURE SOURCE. FROM THE REPORT 3 PATIENTS HAD GROIN PSEUDOANEURYSM. ALL PATIENTS WERE CONSERVATIVELY TREATED WITHOUT LONG-TERM SEQUELAE. ARTICLE TITLE: ¿TAILORED ATRIAL SUBSTRATE MODIFICATION BASED ON LOW-VOLTAGE AREAS IN CATHETER ABLATION OF ATRIAL FIBRILLATION.¿ THE AIM OF THIS STUDY WAS TO ASSESS THE INCIDENCE OF LOW-VOLTAGE AREAS (LVAS) IN PATIENTS UNDERGOING ATRIAL FIBRILLATION CATHETER ABLATION, THE DISTRIBUTION OF LVAS WITHIN THE LA, AND THE EFFECT OF AN INDIVIDUALIZED ABLATION STRATEGY ON LONG-TERM RHYTHM OUTCOMES. THE STUDY WAS CONDUCTED BETWEEN (B)(4) 2010 AND (B)(4) 2011. FROM THE REPORT OTHER PROCEDURE-RELATED MINOR COMPLICATIONS WERE OBSERVED: 1 PATIENT HAD TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS TREATED CONSERVATIVELY WITHOUT LONG-TERM SEQUELAE. ONE PATIENT HAD GASTROPARESIS. THE PATIENT WAS TREATED CONSERVATIVELY WITHOUT LONG-TERM SEQUELAE. ONE HAD FLUID OVERLOAD WITH CONSECUTIVE PULMONARY EDEMA. THE PATIENT WAS TREATED CONSERVATIVELY WITHOUT LONG-TERM SEQUELAE. THERE ARE NO DEATH EVENTS OR DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. OTHER BWI PRODUCTS WERE INVOLVED DURING THIS TRIAL: LASSO, CARTO. THERAPY COOLPATH; ST. JUDE MEDICAL, INQUIRY OPTIMA OR REFLEXION SPIRAL; ST. JUDE MEDICAL, ENSITE VELOCITY NAVX; ST. JUDE MEDICAL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774874 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 61 YR Life Threatening