BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11729172 · Received April 26, 2021

    Report

    Report Number
    2029046-2021-00663
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 6, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION AND FORCE SENSOR EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A HOLE AND A REDDISH MATERIAL INSIDE THE PEBAX IN THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. FORCE SENSOR TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND NO FORCE ISSUES WERE DETECTED DURING THE ANALYSIS. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. ALTHOUGH NO FORCE ISSUE COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT; IT SHOULD BE NOTED THAT FOR PRODUCT FORCE FAILURE, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION IN THE CARTO 3 SYSTEM MANUAL THAT SHOULD BE CONSIDERED: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. THE CUSTOMER COMPLAINT REGARDING FORCE ISSUE WAS UNABLE TO DUPLICATE DURING THE PRODUCT INVESTIGATION, HOWEVER, THE FOREIGN MATERIAL FOUND INSIDE THE PEBAX AREA COULD BE RELATED TO THE REPORTED ISSUE. THE ROOT CAUSE OF THE DAMAGE ON PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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® SF UNI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER [P030031/S078]. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT IT WAS REPORTED THAT DURING THE AF OPERATION, THERE WAS A PROBLEM WITH THE FORCE OF THE CATHETER. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE INITIAL REPORTED FORCE ISSUE IS NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 1/29/2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. ON 4/6/2021, VISUAL INSPECTION FOUND A REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE WAS ALSO FOUND. THIS FINDING WAS ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE WAS NOT MAINTAINED. THIS EVENT WAS ORIGINALLY CONSIDERED NONREPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH PRODUCT ANALYSIS ON 4/6/2021 AND REASSESSED IT AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621369 THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30445274L

    Patients

    Seq Age Sex Outcome Treatment
    1