BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4571049 · Received March 4, 2015

    Report

    Report Number
    2029046-2015-00047
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    July 1, 2012
    Report Date
    February 18, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: OTHER BWI PRODUCTS WERE USED DURING THIS PROCEDURE: LASSO AND CARTO 3 OTHER DEVICES : NAVX ENSITE VELOCITY (ST JUDE MEDICAL). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT HAD FEMORAL PSEUDOANEURYSM, WHICH WAS TREATED CONSERVATIVELY. MOST PSEUDOANEURYSMS AT VASCULAR ACCESS PUNCTURE SITES CAN BE TREATED WITH A BRIEF, MINIMALLY-INVASIVE INJECTION OF THROMBIN PERFORMED UNDER LOCAL ANESTHESIA. HOWEVER, IN THIS PARTICULAR EVENT, IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. SEVERAL ATTEMPTS HAVE BEEN MADE, HOWEVER NO INFORMATION IS AVAILABLE AT THIS TIME. THEREFORE, TAKING CONSERVATIVE APPROACH BWI WILL REPORT THIS EVENT. BASED ON THE FACTS OF THESE CASES AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: IMAGING AND EPICARDIAL SUBSTRATE ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS LATE AFTER MYOCARDITIS OBJECTIVES: IN THE CURRENT STUDY, CLINICAL, ELECTROANATOMICAL MAPPING (EAM), IMAGING, AND (CA) CATHETER ABLATION STRATEGIES IN A SERIES OF PATIENTS PRESENTING WITH VT AND A HISTORY OF MYOCARDITIS ARE PRESENTED. BETWEEN (B)(6) 2010 AND (B)(6) 2012, 26 CONSECUTIVE PATIENTS UNDERWENT IMAGING-GUIDED CAOF MYOCARDITIS-RELATED VENTRICULAR ARRHYTHMIAS, 23 OF 26 USING A COMBINED ENDO¿EPICARDIAL APPROACH. SEGMENT PER SEGMENT CORRESPONDENCE OF LATE ENHANCED (LE) SCAR LOCALIZATION WITH EAM SCAR WAS ASSESSED IN ALL PATIENTS WITH AVAILABLE UNI/BIPOLAR MAPS (N ¼ 19). INDUCED VTS WERE TARGETED PRIOR TO SUBSTRATE MODIFICATION. 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 3.5 MM DISTAL-TIP IRRIGATED CATHETER NAVISTAR OR CELSIUS. THEREFORE THIS EVENT WILL BE REPORTED UNDER THE NAVISTAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150421 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR