BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6211013 · Received December 28, 2016

    Report

    Report Number
    2029046-2016-00270
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 22, 2014
    Report Date
    December 29, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PRODUCT: CIRCULAR ABLATION CIRC LOOP CATHETER, MODEL #: D-1322-14-SI, LOT #: 16104791LA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER, INC., IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SYMPTOMATIC ATRIAL FIBRILLATION WITH A NAVISTAR THERMOCOOL CATHETER AND SUFFERED PULMONARY EDEMA LESS THAN 7 DAYS POST-PROCEDURE REQUIRING MEDICATION AND PROLONGED INTUBATION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. CARDIOVASCULAR MEDICAL HISTORY INCLUDES CONGESTIVE HEART FAILURE, HYPERTENSION, LEFT VENTRICULAR HYPERTROPHY, AND A PACEMAKER FOR SICK SINUS SYNDROME. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. IT WAS NOTED THAT THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT (CVA) APPROXIMATELY 2 MONTHS POST-PROCEDURE AND EXPIRED APPROXIMATELY 2.5 MONTHS POST-PROCEDURE. PRINCIPAL INVESTIGATOR ASSESSED THE CVA AS SEVERE, SERIOUS, NOT DEVICE-RELATED, AND NOT PROCEDURE-RELATED. SINCE THE CVA WAS NOT RELATED TO DEVICE OR PROCEDURE, IT IS NOT MDR REPORTABLE. THE DEATH EVENT WAS IDENTIFIED AS THE OUTCOME OF THE CVA. 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
    860656 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| R