BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6211267 · Received December 28, 2016

    Report

    Report Number
    2029046-2016-00272
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    September 9, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT MEDICAL PRODUCTS: CIRCULAR ABLATION CIRC LOOP CATHETER; MODEL #: D-1322-14-SI; LOT #: 15955581L. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER, INC., IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SYMPTOMATIC ATRIAL FIBRILLATION WITH A NAVISTAR THERMOCOOL CATHETER AND SUFFERED HYPERVOLEMIA LESS THAN 7 DAYS POST-PROCEDURE REQUIRING MEDICATION AND PROLONGED HOSPITALIZATION. ISSUE RESOLVED WITHOUT SEQUELAE. CARDIOVASCULAR MEDICAL HISTORY INCLUDES HYPERTENSION. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860990 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 56 YR Hospitalization| R