BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4492259 · Received February 6, 2015

    Report

    Report Number
    2029046-2015-00033
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    December 31, 2012
    Report Date
    January 19, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE, THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO¿ XP SYSTEM, US CATALOG # FG540000M, SERIAL # UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT WITH ASD SUFFERED ACUTE HEART FAILURE AFTER THE PROCEDURE. THE PATIENT FULLY RECOVERED AFTER CONSERVATIVE MANAGEMENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. TITLE: ¿CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH ATRIAL SEPTAL DEFECT: LONG-TERM FOLLOW-UP RESULTS¿. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE AND COMPARE THE LONG-TERM EFFICACY OF AF ABLATION IN PATIENTS WITH UNREPAIRED ATRIAL SEPTAL DEFECT (ASD) WITH THOSE WITH NORMAL SEPTAL ANATOMY. THE STUDY WAS CONDUCTED FROM JANUARY 2008 TO DECEMBER 2012. THE 18 CONSECUTIVE PATIENTS WERE IDENTIFIED WITH MEDICALLY REFRACTORY AF AND AN ASD. FROM THIS REPORT OTHER EVENTS WERE REPORTED. TWO PATIENTS SUFFERED FROM HEMATOMA. ALL OF THE PATIENTS RECOVERED FULLY AFTER CONSERVATIVE MANAGEMENT. SUSPECTED DEVICE IS NAVSITAR 8 MM. HOWEVER, CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN. CARTO XP MAPPING SYSTEM WAS ALSO USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87566 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening