BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16832796 · Received April 28, 2023

    Report

    Report Number
    2029046-2023-00914
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    January 24, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE : (B)(6). THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON (B)(6) 2023. THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2023. VISUAL ANALYSIS REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE DEVICE. A MAGNETIC SENSOR FUNCTIONALITY TEST WAS PERFORMED, AND THE CATHETER WAS WORKING CORRECTLY; HOWEVER, THE HOLE AT THE PEBAX WITH REDDISH MATERIAL INSIDE COULD BE RELATED TO THE MAGNETIC SENSOR ISSUE. MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE CARTO 3 SYSTEM MANUAL: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. ON OTHER HAND, REGARDING THE ADDITIONAL FINDING OBSERVED, THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING INFORMATION: 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. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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) PROCEDURE WITH A A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE DEVICE. INITIALLY, IT WAS REPORTED THAT WHEN THE CATHETER WAS CONNECTED, A MAGNETIC SENSOR ERROR WAS DISPLAYED. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE MAGNETIC SENSOR ERROR WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON (B)(6) 2023 THAT THERE WAS A REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE DEVICE. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046771 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30916764L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THMCL SMTCH SF BID, TC, D-F