BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5845563 · Received August 3, 2016

    Report

    Report Number
    9673241-2016-00478
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    September 4, 2015
    Report Date
    July 15, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN THE USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS A SIMILAR DEVICE TO THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS PART OF THE (B)(6) CLINICAL STUDY: IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL CATHETER AND SUFFERED A PERICARDIAL EFFUSION REQUIRING MEDICATION MORE THAN 7 DAYS POST-PROCEDURE. PATIENT HAS A MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, AND HYPERTENSION. ISSUE WAS RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT TO BE OF MODERATE SEVERITY, NOT DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495893 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-SI 17235806L

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention