BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9673241-2014-00047

    MDR report key: 3627376 · Received February 13, 2014

    Report

    Report Number
    9673241-2014-00047
    Event Type
    Injury
    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
    Adverse Event
    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 WITH A 4 MM ITC WITH 12 IRRIGATION HOLES (GROUP-B)." IT WAS INDICATED WITHIN THE ARTICLE: "ONE PATIENT IN THE RNS AND ONE PATIENT IN THE MN-GROUP DEVELOPED A GROIN HEMATOMA AFTER THE PROCEDURE, WHICH RESULTED IN PROLONGED HOSPITAL STAY IN BOTH PATIENTS BUT DID NOT REQUIRE SURGICAL INTERVENTION." PER THE AVAILABLE INFORMATION, AS THE PATIENT REQUIRED PROLONGED HOSPITALIZATION, THIS COMPLAINT BECAME REPORTABLE. 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 JANUARY 1ST 2013 WAS SELECTED AS EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95852 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization