BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20341626 · Received October 1, 2024

    Report

    Report Number
    2029046-2024-03236
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009811
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE DEVICE WAS CONNECTED TO CARTO 3 SYSTEM AND IT WAS VISUALIZED AND RECOGNIZED CORRECTLY. NO MAGNETIC ISSUES OR ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE MAGNETIC ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. 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. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING RECOMMENDATIONS: TO REMOVE ANY COAGULUM, IF PRESENT, A STERILE GAUZE PAD DAMPENED WITH STERILE SALINE MAY BE USED TO GENTLY WIPE THE TIP SECTION CLEAN. DO NOT SCRUB OR TWIST THE TIP ELECTRODE BECAUSE DAMAGE TO THE TIP ELECTRODE BOND MAY OCCUR AND LOOSEN THE TIP ELECTRODE OR DAMAGE THE CONTACT FORCE SENSOR AND AFFECT MEASUREMENT ACCURACY. PRIOR TO REINSERTION, ENSURE THAT THE IRRIGATION HOLES ARE NOT PLUGGED. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER, ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION. ANY SHEATH < 8.5 F IS CONTRAINDICATED. 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 (AFIB) CARDIAC PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY, IT WAS REPORTED THAT DURING PROCEDURE, A MAGNETIC SENSOR ERROR CODE 105 WAS DISPLAYED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE MAGNETIC SENSOR ERROR 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. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 02-SEP-2024, A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX WAS OBSERVED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 02-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948095 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31290637L 10846835009811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown