BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6067269 · Received October 31, 2016

    Report

    Report Number
    9673241-2016-00748
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 7, 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
    JA
    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. 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 P030031/S053. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER AND A CLOT FORMATION OCCURRED. AFTER THE PROCEDURE, A CLOT/COAGULUM WAS STUCK TO THE TIP OF THE SMARTTOUCH SF CATHETER WHEN THE CATHETER WAS REMOVED FROM THE LONG SHEATH. THERE WERE NO ERROR MESSAGED AND THE PHYSICIAN DID NOT SEE ANY PRODUCT PROBLEM. THERE WERE NO ISSUES WITH FLOW OR TEMPERATURE OF THE CATHETER. THE GENERATOR WAS SET TO POWER CONTROL MODE DURING THE PROCEDURE. THE PATIENT DID RECEIVE ANTICOAGULANT; HOWEVER, THE TYPE USED IS UNKNOWN. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THIS EVENT HAS BEEN ASSESSED AS MDR REPORTABLE BECAUSE CLOT/COAGULUM HAS POOR ADHERENCE TO CATHETERS AND TRANSSEPTAL SHEATHS AND IT COULD BE A POTENTIAL SOURCE OF EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719741 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-01-S 17422315L

    Patients

    Seq Age Sex Outcome Treatment
    1