BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3821226 · Received May 20, 2014

    Report

    Report Number
    9673241-2014-00194
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVESTIGATION IS STILL IN PROGRESS. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A PULMONARY VEIN ISOLATION (PVI), IT WAS REPORTED THAT THE TEMPERATURE OF THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS INCREASING DURING ABLATION TOWARDS THE END OF THE PROCEDURE. PHYSICIAN MANAGED TO COMPLETE THE PROCEDURE USING THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES. ON MAY 6TH, FAILURE ANALYSIS LAB FOUND CHAR ON PROXIMAL END OF TIP DOME (MORE THAN ONE MILLIMETER). THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND CHAR WAS PRESENT ON THE TIP DOME. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. PER THE EVENT AND THE CHAR FOUND, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND FOUND WITHIN SPECIFICATIONS. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION (PVI), IT WAS REPORTED THAT THE TEMPERATURE OF THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS INCREASING DURING ABLATION TOWARDS THE END OF THE PROCEDURE. PHYSICIAN MANAGED TO COMPLETE THE PROCEDURE USING THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES. ON (B)(6) FAILURE ANALYSIS LAB FOUND CHAR ON PROXIMAL END OF TIP DOME (MORE THAN ONE MILLIMETER). DUE TO THIS FINDING AND THE POTENTIAL RISK TO THE PATIENT, IT WAS DETERMINED FOR THIS COMPLAINT TO BE REPORTABLE. AWARENESS DATE CHANGED FROM (B)(6) TO (B)(6), 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299629 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1