BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5097058 · Received September 23, 2015

    Report

    Report Number
    9673241-2015-00659
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 25, 2015
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED ON (B)(6) 2015 THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO ADDITIONAL INVESTIGATION, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE FOR TC BREAKAGE ISSUE ON THE TIP SECTION FOR ST AND ST SF. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 2, 2015 FROM BWI REPRESENTATIVE REGARDING THE PRODUCT RETURNED CONDITION: THE PRODUCT CONDITION WAS NOT NOTICED PRIOR TO USE IT ON THE PATIENT AND UPON WITHDRAWAL. IT WAS ALSO NOT OBSERVED PRIOR TO SENDING IT BACK TO OUR ANALYSIS SITE. CONFIRMED NO PATIENT CONSEQUENCE OCCURRED. (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND NO TEMPERATURE WAS BEING DISPLAYED. DURING A PROCEDURE, THE TEMPERATURE OF THE CATHETER WAS NO LONGER SHOWN. TROUBLESHOOTING WAS PERFORMED BY EXCHANGING CABLE WITH NO RESOLUTION, AFTER THE CATHETER WAS REPLACED WITH A NEW ONE, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE PRODUCT RETURNED CONDITION ON AUGUST 26, 2015 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE DUE TO THE LOSS OF INTEGRITY OF THIS CATHETER AND WIRES WERE EXPOSED ALONG THE SHAFT WITHIN THE USABLE LENGTH OF THE CATHETER. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THE SHAFT CRACKED AT 11 CM FROM THE CLIENT TIP (METAL EXPOSED). THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND THE THERMOCOUPLE TEST FAILED. FURTHER EXAMINATION REVEALED THAT THE THERMOCOUPLE WIRES WERE DISCONNECTED INSIDE THE DOME. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT WAS CONFIRMED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE FOR SMARTTOUCH BROKEN SHAFT ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND NO TEMPERATURE WAS BEING DISPLAYED. DURING A PROCEDURE, THE TEMPERATURE OF THE CATHETER WAS NO LONGER SHOWN. TROUBLESHOOTING WAS PERFORMED BY EXCHANGING CABLE WITH NO RESOLUTION, AFTER THE CATHETER WAS REPLACED WITH A NEW ONE, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE PRODUCT RETURNED CONDITION ON (B)(6) 2015 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE DUE TO THE LOSS OF INTEGRITY OF THIS CATHETER AND WIRES WERE EXPOSED ALONG THE SHAFT WITHIN THE USABLE LENGTH OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629382 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17194388M

    Patients

    Seq Age Sex Outcome Treatment
    1