BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8698091 · Received June 13, 2019

    Report

    Report Number
    2029046-2019-03268
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 8, 2019
    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

    (B)(6). THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON MAY 1, 2019 AND THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. INVESTIGATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THEN, DURING THE SECOND VISUAL INSPECTION THE POLYURETHANE (PU) WAS FOUND DAMAGED UNDER ELECTRODE #2. THEN, AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, A SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED ON THE DAMAGED AREA AND THE RESULTS SHOWED DAMAGE ON THE PU BORDER OF ELECTRODE TWO. IT WAS OBSERVED THAT THERE WAS A SMALL PORTION OF THE ELECTRODE NOT COVERED BY PU. IT WAS ALSO OBSERVED THAT THERE WAS DAMAGE AND A HOLE ON THE PEBAX BENEATH THE PU. THE OBJECT THAT CAUSED THE DAMAGE WAS UNKNOWN. NO OTHER ANOMALIES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED.  THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE PU AND THE 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB NOTED ELECTRODE DAMAGE AND A HOLE ON THE PEBAX. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER HAD MUCH INTERFERENCE/NOISE. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. THE INTERFERENCE/NOISE ISSUE WAS ASSESSED AS NOT REPORTABLE AS THE RISK TO THE PATIENT WAS LOW. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND NOTED ON MAY 17, 2019 THAT THERE WAS DAMAGE IN THE POLYURETHANE (PU) UNDER ELECTRODE #2. HOWEVER, AFTER ADDITIONAL REVIEW, THE DAMAGE WAS NOT CLEAR. THEREFORE, ADDITIONAL TESTING WAS TO BE PERFORMED. WITH THE INFORMATION AVAILABLE AT THAT TIME, THIS RETURNED CONDITION WAS ASSESSED AS NOT REPORTABLE SINCE THE DEVICE INTEGRITY SEEMED TO BE MAINTAINED AND NO INTERNAL COMPONENTS EXPOSED TO PATIENT. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. ADDITIONAL SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED ON MAY 22, 2019. FIGURE 1 SHOWED DAMAGE ON THE PU BORDER OF ELECTRODE TWO. A SMALL PORTION OF THE ELECTRODE WAS NOT COVERED BY PU. FIGURE 3 SHOWED DAMAGED AND A HOLE ON PEBAX BENEATH THE PU. OBJECT THAT CAUSED THE DAMAGE WAS UNKNOWN. NO OTHER ANOMALIES WERE OBSERVED. THE ELECTRODE DAMAGE AND THE HOLE ON THE PEBAX WERE ASSESSED AS REPORTABLE ISSUES. THE AWARENESS DATE FOR THESE ISSUES IS MAY 22, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490538 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30036358L

    Patients

    Seq Age Sex Outcome Treatment
    1