BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 4942889 · Received July 27, 2015

    Report

    Report Number
    9673241-2015-00479
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 9, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT, THE PRODUCT WAS LISTED AS THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER WITH CATALOG# D131500, MFG# (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 02/28/2016 THAT THE ACTUAL PRODUCT IS THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WITH CATALOG# BNI35DFH MFG# (B)(4). THE LOT# REMAINS UNKNOWN. MANUFACTURER'S REF. NO: (B)(4).

    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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT NAME: CARTO 3 RMT SYSTEM, US CATALOG #: FG560000, SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND AT THE END OF THE CASE AFTER 3 HOURS OF GENERAL ANESTHESIA, BEFORE PULLING OUT THE CATHETER, THE PATIENT SUFFERED A CARDIAC TAMPONADE NOTICED BY ULTRASOUND WHICH REQUIRED TO DRAINED THE EFFUSION. APPROXIMATELY 600ML WERE REMOVED AND NO ADDITIONAL TREATMENT WAS REQUIRED. IT WAS NOTED THAT THIS PATIENT HAD A MEDICAL HISTORY OF MYOCARDIAL INFARCTION AND CARDIOMYOPATHY THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS RELATED TO PATIENT¿S CONDITION. SETTINGS DURING THE EVENT INCLUDE: 40 WATTS OF POWER AND AN IRRIGATION OF 30 ML. THIS EVENT IS BEING REPORTED CONSERVATIVELY SINCE WE CANNOT RULE OUT THAT THE BWI CATHETER MAY HAVE BEEN INVOLVED IN THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486925 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER SIMILAR DEVICE D131501, PMA # P030031/S034 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-00 UNKNOWN_D-1315-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R