BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16895010 · Received May 9, 2023

    Report

    Report Number
    2029046-2023-00979
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    February 14, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL INSPECTION, SCREENING, TEMPERATURE, IMPEDANCE, COOL FLOW PUMP, AND PRESSURE GAGE TESTS OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED CHAR ON THE TIP, AND BLOOD IN THE PEBAX. A SCREENING TEST WAS PERFORMED, HOWEVER, ERROR 105 APPEARED ON THE SYSTEM DUE TO AN OPEN CIRCUIT IN THE TIP AREA. THE TEMPERATURE, IMPEDANCE, COOL FLOW PUMP, AND PRESSURE GAGE TESTS WERE PERFORMED AND THE DEVICE WAS FOUND TO BE WORKING CORRECTLY. NO TEMPERATURE, IRRIGATION OR IMPEDANCE ISSUES WERE OBSERVED. A MICROSCOPIC EXAMINATION WAS PERFORMED IN THE PEBAX, AND A HOLE WAS OBSERVED WITH BLOOD IN THE INTERNAL COMPONENTS. HOWEVER, THE ROOT CAUSE OF THE DAMAGE COULD BE RELATED TO THE HANDLING SINCE THERE ARE CONTROL INSPECTION POINTS TO AVOID THESE ISSUES IN THE PROCESS. THE ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING GUIDELINE: MONITORING THE TEMPERATURE FROM THE ELECTRODE DURING THE APPLICATION OF RF CURRENT ENSURES THAT THE IRRIGATION FLOW RATE IS MAINTAINED. USING TIP TEMPERATURE TO GUIDE ABLATION COULD RESULT IN DEEPER LESIONS AND INCREASED RISK FOR COLLATERAL DAMAGE. IF FORCE READINGS MIGHT BE INACCURATE OR ANOTHER CATHETER IS IN PROXIMITY: AN ALERT MESSAGE APPEARS, FORCE READINGS ON THE DASHBOARD ARE DISPLAYED IN GRAY, AND THE FORCE GRAPH IS COLORED WHITE. RESOLVE THE ISSUE ACCORDING TO THE DIRECTIONS IN THE ALERT MESSAGE TO ENABLE FORCE MEASUREMENT. YOU CAN ALSO CONTINUE THE STUDY WITHOUT FORCE DATA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. BIOSENSE WEBSTER'S QUALITY PROCESS ENSURES ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: PROBLEM DUE TO THROMBOSIS ACTIVATION (C010604) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: CAUTERY TIP (G01002) WERE SELECTED AS RELATED TO THE ISSUE OF CHAR. 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 ISSUE FOREIGN MATERIAL AND A HOLE IN THE PEBAX. INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR (G03012) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED FORCE ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER ABOUT 90% OF THE PROCEDURE AND WHEN COMING ON ABLATION THERE WAS AN ERROR 85 (FORCE IS NOT DISPLAYED DUE TO HIGH INTERFERENCE.) DISPLAYED ON THE CARTO 3 SYSTEM. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THE CALLER STATED THAT AFTER REPLACING THE CATHETER, CHAR WAS DISCOVERED ON THE TIP OF THE ORIGINAL CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THE CHAR WAS FOUND ON THE TIP ELECTRODE. HIGH FORCE ERROR RELAYED WHEN THE PHYSICIAN CAME OUT ON RF. THE SMARTALATE GENERATOR WAS IN POWER CONTROL MODE, HIGH FORCE 40G CUT OFF. POWER 35W, IMPEDANCE 98, TEMP NOT AVAILABLE. THERE WERE NO ISSUES RELATED TO TEMPERATURE. THE PATIENT WAS ANTICOAGULATED AND MAINTAINED THROUGHOUT THE CASE. AN ABBOT SL1 9F SHEATH WAS USED IN THIS CASE. THERE WAS NO DIFFICULTY MANEUVERING THE DEVICE AND THE CATHETER PEBAX WAS NOT NOTICED TO BE DAMAGED. THEY PHYSICIAN DID NOT CONSIDER THE CHAR /COAGULUM/THROMBUS/CLOT IS NOT EXCESSIVE. THE CUSTOMER¿S REPORTED ISSUES OF FORCE, CHAR AND FOREIGN MATERIAL IN THE PEBAX ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 12-APR-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE WITH BLOOD IN THE INTERNAL COMPONENTS OF THE PEBAX AREA. THIS FINDING WAS REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878176 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134804 30954043L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ABBOT SL1 9F SHEATH| CARTO 3 SYSTEM| SMARTABLATE PUMP SPARE-US| UNKNOWN CABLE