BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4925350 · Received July 20, 2015

    Report

    Report Number
    2029046-2015-00196
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    December 31, 2013
    Report Date
    June 25, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. 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. CONCOMIITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO 3 MAPPING SYSTEM. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: CLOSED-LOOP IRRIGATED CATHETER (CHILI, BOSTON SCIENTIFIC), HEMODYNAMIC SUPPORT DEVICES (EXTRACORPOREAL MEMBRANE OXYGENATION (IMPELLA, ABIOMED), NAVX (ST. JUDE MEDICAL). (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4). ARE RELATED TO THE SAME ARTICLE. MANUFACTURER'S REF. NO: (B)(4). THE DEVICES WERE NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT TEN PATIENTS SUFFERED HEART BLOCK AFTER VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THESE EVENTS ARE UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿FREEDOM FROM RECURRENT VENTRICULAR TACHYCARDIA AFTER CATHETER ABLATION IS ASSOCIATED WITH IMPROVED SURVIVAL IN PATIENTS WITH STRUCTURAL HEART DISEASE: AN INTERNATIONAL VT ABLATION CENTER COLLABORATIVE GROUP STUDY.¿ THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE ASSOCIATION BETWEEN VT RECURRENCE AFTER ABLATION AND SURVIVAL IN PATIENTS WITH SCAR-RELATED VT. THE STUDY WAS CONDUCTED BETWEEN 2002 AND 2013. OTHER SERIOUS AND NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE (SERIOUS EVENTS ARE REPORTED TO FDA SEPARATELY): - 2 PATIENTS DEATH; - 6 PATIENTS CARDIOPULMONARY RESUSCITATION; - 16 PATIENTS PERICARDIAL EFFUSION (EPICARDIAL ABLATION); - 8 PATIENTS CARDIAC TAMPONADE; - 11 PATIENTS PERICARDIAL EFFUSION; - 32 PATIENTS VASCULAR COMPLICATION; - 10 PATIENTS STROKE; - 7 PATIENTS THROMBUS; - 4 PATIENTS CORONARY ARTERY INJURY; SUSPECTED DEVICE IS NAVISTAR, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468788 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other