BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6210960 · Received December 28, 2016

    Report

    Report Number
    2029046-2016-00269
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 25, 2014
    Report Date
    November 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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-S, LOT #: 16045945L. NON-BIOSENSE WEBSTER INC.- ST. JUDE MEDICAL AGILIS SHEATH. (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 A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR SYMPTOMATIC ATRIAL FIBRILLATION WITH A NAVISTAR THERMOCOOL CATHETER AND SUFFERED PERICARDITIS REQUIRING MEDICATION. LESS THAN 7 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED PERICARDITIS. PATIENT WAS GIVEN PARACETAMOL AND DICLOFENAC. ON POST-PROCEDURE DAY 2, THE ISSUE RESOLVED WITHOUT SEQUELAE. PATIENT REQUIRED ONE EXTRA DAY OF HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. MEDICAL HISTORY INCLUDES HYPERTENSION, ATRIAL TACHYCARDIA (BILATERAL), AND DIABETES MELLITUS TYPE II. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, POSSIBLY DEVICE-RELATED (NMARQ), AND DEFINITELY INDEX PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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
    860892 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 51 YR Hospitalization| R