BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4283045 · Received November 27, 2014

    Report

    Report Number
    9673241-2014-00530
    Event Type
    Injury
    Date Received
    November 27, 2014
    Date of Event
    February 1, 2013
    Report Date
    November 13, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    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 ¿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 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053. 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 THE 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: BWI CONCOMITANT PRODUCT USED: PRODUCT NAME: CARTO® 3 SYSTEM: US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. NON-BWI PRODUCTS USED: ENDRY¿S CO-AXIAL NEEDLE (COOK MEDICAL, (B)(4) USA) OR BROCKENBROUGH NEEDLE (ST. JUDE MEDICAL, (B)(4), USA). REMOTE ROBOTIC NAVIGATION (RRN¿SENSEI ROBOTIC CATHETER SYSTEM, HANSEN MEDICAL INC.,(B)(4), USA). HANSEN ARTISAN SHEATH (HANSEN MEDICAL INC.). (B)(4) ARE RELATED TO THE SAME EVENT. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINS IS FROM LITERATURE SOURCE. FROM THE ARTICLE REPORT 2 PATIENTS HAD VASCULAR PSEUDOANEURYSM. TITLE: COMPARISON OF ROBOTIC AND MANUAL PERSISTENT AF ABLATION USING CATHETER CONTACT FORCE SENSING: AN INTERNATIONAL MULTICENTER REGISTRY STUDY. OBJECTIVES: THE PRIMARY AIM OF THIS STUDY WAS TO COMPARE REMOTE ROBOTIC NAVIGATION (RRN) AND MANUAL ABLATION USING CONTACT FORCE SENSING (CFS) IN CONSECUTIVE, CONTEMPORARY PATIENTS TO ASSESS WHETHER THE WELL-DESCRIBED DIFFERENCES BETWEEN THE TWO NAVIGATION MODES WITHOUT CONTACT FORCE SENSING WERE MAINTAINED OR EXAGGERATED THROUGH THE USE OF THIS TECHNOLOGY. THIS STUDY COMBINED PROSPECTIVE REGISTRIES OF CONSECUTIVE PATIENTS UNDERGOING THEIR FIRST CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION BY FEBRUARY 2013 FROM THREE GROUPS BASED IN SIX CENTERS IN THE UNITED KINGDOM AND SOUTH AFRICA. INCLUDED WERE THE THERMOCOOL SMARTTOUCH CATHETER (BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA FROM THIS REPORT THERE WERE OTHER ADVERSE EVENTS: -1 PATINET SUFFERED FROM HEMATOMA. -7 PATIENTS WITH PERICARDIAL EFFUSION ¿ NONSIGNIFICANT EFFUSIONS: NOT ASSOCIATED WITH HEMODYNAMIC COMPROMISE AND <1 CM IN SIZE. DIAGNOSED ON ROUTINE POST PROCEDURE ECHOCARDIOGRAPHY. -1 PATIENT HAD PHRENIC NERVE PARALYSIS. -1 PATIENT HAD TRANSIENT ISCHEMIC ATTACK. -1 PATIENT HAD CARDIAC TAMPONADE. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE SMARTTOUCH CATHETER. ONE MORE BWI PRODUCT WAS USED DURING THIS PROCEDURE:CARTO IN THE CFS GROUPS THAN IN THE NON-CFS GROUPS. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770251 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening