BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6014150 · Received October 10, 2016

    Report

    Report Number
    9673241-2016-00683
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 14, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. THIS SUPPLEMENTAL IS A CORRECTION AS THE PRODUCT WAS FDA APPROVED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) 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 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 PMA #P030031/S053. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAV CATHETER AND A CLOT WAS FOUND ON THE END OF THE CATHETER AT THE END OF THE PROCEDURE WHEN WITHDRAWING THE CATHETER. THE MATERIAL APPEARED TO BE COAGULUM. ABLATIONS WERE PERFORMED BETWEEN 20 AND 30 WATTS. IRRIGATION FLOW SETTING WAS 8ML/MIN WITH HEPARINIZED PHYSIOLOGICAL SALINE. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO TEMPERATURE OR FLOW OF THE CATHETER. THE PATIENT DID RECEIVED SALINE SOLUTION AS ANTICOAGULANT. THE CATHETER WAS NOT REPLACED BECAUSE THE PROCEDURE WAS COMPLETE. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS EVENT IS MDR REPORTABLE SINCE CLOT/COAGULUM HAS POOR ADHERENCE TO CATHETERS AND TRANSSEPTAL SHEATHS, IT COULD BE A POTENTIAL SOURCE OF EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667021 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17470176L

    Patients

    Seq Age Sex Outcome Treatment
    1