BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16881673 · Received May 5, 2023

    Report

    Report Number
    2029046-2023-00970
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2023. ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, NO CHAR WAS OBSERVED ON TIP; HOWEVER, A REDDISH MATERIAL WAS OBSERVED ON THE PEBAX SECTION AND THIS COULD BE RELATED TO THE CUSTOMER COMPLAINT; HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. ALSO, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PEBAX. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY; IT CAN BE THE USUAL RESULT OF THE ABLATION PROCESS; HOWEVER, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INSTRUCTION: MONITORING THE TEMPERATURE FROM THE ELECTRODE DURING THE APPLICATION OF RF CURRENT ENSURES THAT THE IRRIGATION FLOW RATE IS BEING MAINTAINED THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE PRODUCT ANALYSIS WAS PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI THEN CONDUCTED A VISUAL INSPECTION, A TEMPERATURE AND IMPEDANCE TEST AND COOL FLOW PUMP AND PRESSURE GAGE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE. NO CHAR WAS FOUND. THE TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. THE COOL FLOW PUMP AND PRESSURE GAGE TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATING CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CHAR ISSUE REPORTED BY THE CUSTOMER COULD BE RELATED TO THE BLOOD INSIDE THE PEBAX; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE HOLE ON THE PEBAX CANNOT BE DETERMINED, IT SHOULD BE NOTED THAT THE DAMAGE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE (C22) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) WERE SELECTED AS RELATED TO THE ¿PICTURE¿ PROVIDED. 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 CUSTOMER¿S REPORTED ¿CHAR¿ AND ¿FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE IN ADDITION TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿FOREIGN MATERIAL INSIDE THE PEBAX WITH EXTERNAL DAMAGE¿. 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 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS REPORTED THAT CHAR, THE SOLID CARBONIZED MATERIAL, WAS FORMED CLOSE TO OR ON ELECTRODE(S) OF THE CATHETER DURING THE ABLATION PROCEDURE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CHAR WAS LOCATED ON THE TIP ELECTRODE. THE SYSTEMS DID NOT PRESENT ANY ERROR MESSAGE AND DID NOT SEE ANY PRODUCT PROBLEM. THE WHOLE COURSE WAS 40 W WITH A HIGH FLOW RATE OF 15 ML/MIN. THE GENERATOR PARAMETERS AND THRESHOLDS ARE UNKNOWN. THE TEMPERATURE, IMPEDANCE AND POWER ARE UNKNOWN. PICTURE PROVIDED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE SHEATH USED IN THE PROCEDURE WAS THE SYNAPTIC MEDICAL, INTRACARDIAC GUIDE SHEATH GROUP AND ACCESSORIES, S0856332L1. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THE CATHETER PEBAX WAS NOT PHYSICALLY DAMAGED. THE INFORMATION REPORTED WAS ASSESSED AS NON REPORTABLE FOR BOTH A CHAR ISSUE AND FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2023 THERE WAS REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE WERE OBSERVED. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678516 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30902157L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CN CARTO 3 SYSTEM (FOR CHINA).| SYNAPTIC MEDICAL, INTRACARDIAC GUIDE SHEATH.| UNKNOWN BRAND CATHETER.| UNKNOWN BRAND GENERATOR.