BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19661126 · Received July 2, 2024

    Report

    Report Number
    2029046-2024-02213
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 2, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THERE WAS A REDDISH MATERIAL AND A HOLE ON THE PEBAX'S SURFACE. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MAGNETIC SENSOR FUNCTIONALITY TEST WAS PERFORMED, AND THE DEVICE WAS VISUALIZED AND RECOGNIZED CORRECTLY. NO MAGNETIC, NOR ELECTRIC ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE CURRENT ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE DAMAGE TO THE PEBAX COULD CAUSE THE CURRENT LEAKAGE EXPERIENCED BY THE CUSTOMER. IN RELATION TO THE REDDISH MATERIAL INSIDE THE PEBAX, THE INSTRUCTIONS FOR USE STATES: WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT. TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE, OR MAY DAMAGE THE CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX'S SURFACE. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, LEAKAGE CURRENT WAS DETECTED ON PATIENT INTERFACE UNIT (PIU) RL INPUT. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CURRENT LEAKAGE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 05-JUN-2024, THERE WAS REDDISH MATERIAL AND A HOLE ON THE PEBAX'S SURFACE. THE HOLE IN THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 05-JUN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507833 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31236480L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown