BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4243551 · Received November 11, 2014

    Report

    Report Number
    9673241-2014-00480
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A) 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® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053. B) THERE IS NO INFORMATION ON THE PRODUCT AVAILABILITY, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. C) MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THESE EVENTS, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), A PHYSICIAN REPORTED TO A BWI EMPLOYEE THAT SOME CARDIAC TAMPONADES EVENTS OCCURRED LAST YEAR ON (B)(6) FACILITY IN (B)(6). FOR NOW, THERE IS NO FURTHER ADDITIONAL INFORMATION REGARDING THE EVENTS REPORTED BY THE PHYSICIAN. THEREFORE, THIS COMPLAINT HAS BEEN CREATED WITH THE AVAILABLE INFORMATION AND TO ENSURE REPORTING THESE EVENTS THROUGH THIS COMPLAINT FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726904 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening