BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 4008675 · Received August 14, 2014

    Report

    Report Number
    2029046-2014-00260
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS THE LOT # 17014582L, THE DEVICE HISTORY RECORDS WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED 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¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053 IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A NOTIFICATION HAS BEEN SENT TO MANUFACTURER (ST. JUDE MEDICAL) FOR THEIR NON-BWI SHEATH PRODUCT (SL1) USED IN THIS EVENT. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AFTER THE PROCEDURE, A CARDIAC TAMPONADE WAS NOTICED WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE PROCEDURE, A STEAM POP WAS NOTICED. THE PATIENT REQUIRED HOSPITALIZATION AND 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 WAS PROCEDURE RELATED DUE TO THE EXCESSIVE RF APPLICATION TIME ON ICT LINE IN ORDER TO REACH THE BI-DIRECTIONAL BLOCK AND THAT WAS NOT RELATED TO THE CATHETER ITSELF. SETTINGS DURING THE EVENT INCLUDE: UNDER POWER CONTROL MODE WITH TEMPERATURE CUT-OFF AT 40 DEGREES CELSIUS AND A NON-BWI PRODUCT SHEATH (ST JUDE MEDICAL - SL1 8,5F).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485045 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1348-05-S 17014582L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R