BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18271271 · Received December 5, 2023

    Report

    Report Number
    2029046-2023-02829
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    August 22, 2023
    Report Date
    December 5, 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 DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THE ROOT CAUSE OF THE DAMAGE ON THE PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. ON THE OTHER HAND, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE CATHETER WAS CONNECTED TO CARTO 3, AND ERROR 105 WAS OBSERVED DUE TO AN OPEN CIRCUIT INSIDE THE TIP. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 31080098L, AND NO INTERNAL ACTIONS WERE IDENTIFIED. 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. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE HOLE ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR (B)(6) WERE SELECTED AS RELATED TO THE OPEN CIRCUIT INSIDE THE TIP. 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 A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (STSF) FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. INITIALLY, IT WAS REPORTED THAT DURING SUPERIOR VENA CAVA (SVC) ABLATION, 20 MINUTES AFTER CATHETER USE, THE READING SUDDENLY TURNED TO HIGH WHILE ABLATION WAS BEING CONDUCTED. THE ISSUE WAS RESOLVED BY REPLACING THE STSF CATHETER TO A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE FORCE 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 FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 08-NOV-2023, THERE WAS A HOLE ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 08-NOV-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232214 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31080098L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown