BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4147963 · Received October 7, 2014

    Report

    Report Number
    9673241-2014-00402
    Event Type
    Death
    Date Received
    October 7, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE, 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED 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¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053. CONCOMITANT MEDICAL PRODUCTS USED: PRODUCT NAME: CARTO® 3 SYSTEM, US CATALOG #: FG540000, SERIAL #: 13509; PRODUCT NAME: STOCKERT 70 RF GENERATOR, US CATALOG #: S7001, SERIAL #: ST-2580; PRODUCT NAME: COOLFLOW® IRRIGATION PUMP, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN; PRODUCT NAME: LASSO NAV ECO CATHETER, US CATALOG #: UNKNOWN, LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION; HOWEVER, IT IS SUSPECTED THAT PATIENT EXPIRED FOR ISSUES RELATED TO ANESTHESIA. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628662 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death