BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9673241-2014-00049

    MDR report key: 3627378 · Received February 13, 2014

    Report

    Report Number
    9673241-2014-00049
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 15, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED BY THE CUSTOMER. 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® SF NAV UNI-DIRECTIONAL CATHETER APPROVED UNDER 510(K)/PMA # P030031/S034. (B)(4).

    Description of Event or Problem · 1

    THE EVENT REPORTED BELOW INVOLVING A BWI PRODUCT (SMART TOUCH UNIDIRECTIONAL) WAS DESCRIBED IN THE SCIENTIFIC LITERATURE JOURNAL: CLIN RES CARDIOL (2013) 102:885¿893, PUBLISHED ON JULY 30TH 2013. ALL INFORMATION HAS BEEN RECEIVED BY BIOSENSE WEBSTER QUALITY DEPARTMENT ON JANUARY 15TH 2014. "IN THIS PILOT STUDY, CIRCUMFERENTIAL PULMONARY VEIN ISOLATION (CPVI) COMBINED WITH LEFT ATRIAL ISTHMUS (LAI)-ABLATION WERE PERFORMED USING A ROBOTIC NAVIGATION SYSTEM (RNS) AND 3D-MAPPING SYSTEM IN 42 PATIENTS WITH PERSISTENT (N = 24, 57.1 %) OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION (AF). ABLATION WAS PERFORMED USING EITHER A 3.5 MM IRRIGATED TIP CATHETER (ITC) WITH 6 (GROUP-A, N = 16; MAX. 40 W, CONTACT FORCE 10¿40 G) OR (AFTER A STEAM POP OCCURRED IN ONE PATIENT) WITH A 4 MM ITC WITH 12 IRRIGATION HOLES (GROUP-B, N = 26; MAX. 30 W, CONTACT FORCE 10¿30 G)." IT WAS INDICATED WITHIN THE ARTICLE: "CHARRING FORMATION AT THE CATHETER TIP WAS OBSERVED IN 6/16 PATIENTS (37.5 %) OF GROUP-A." DUE TO THE AVAILABLE AND CURRENT INFORMATION, THIS COMPLAINT BECAME REPORTABLE DUE TO THE CHAR ISSUE. EACH EVENT HAS BEEN DOCUMENTED AND REPORTED SEPARATELY. THE EVENT OCCURRED IN (B)(6), HOWEVER, THE ACCOUNT INFORMATION WAS NOT CONFIRMED. THE SPECIFIC PRODUCT CODE OF THE THERMOCOOL® SMARTTOUCH¿ USED IS UNKNOWN. NO LOT# HAS BEEN PROVIDED. THE ACTUAL EVENT DATE IS UNKNOWN AND SO (B)(6) 2013 WAS SELECTED AS EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96086 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1