BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16908368 · Received May 10, 2023

    Report

    Report Number
    2029046-2023-00993
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 10, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    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. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND COOL FLOW PUMP AND PRESSURE GAGE TEST OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO ANOMALIES OR DAMAGES ON THE DEVICE. A COOL FLOW PUMP AND PRESSURE GAGE TEST WAS PERFORMED, AND THE DEVICE FAILED THE TEST. AFTERWARD, A MICROSCOPIC EVALUATION OF THE DOME WAS PERFORMED, AND A TRANSPARENT FOREIGN MATERIAL BLOCKING THE IRRIGATION HOLES WAS OBSERVED. FOR THIS REASON, A FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FT-IR) ANALYSIS WAS REQUESTED, AND IT WAS FOUND THAT THE MATERIAL OBSERVED WAS CARBOXYLATE-BASE. THIS FAILURE COULD BE RELATED TO THE OCCLUSION REPORTED BY THE CUSTOMER; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30916839L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. 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: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED CHAR ISSUE. INVESTIGATION FINDINGS: INAPPROPRIATE MATERIAL (C0602)) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: DOME (G04046)) WERE SELECTED AS RELATED TO THE FOREIGN MATERIAL OBSERVED. INVESTIGATION FINDINGS: OPERATIONAL PROBLEM IDENTIFIED (C13) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: DOME (G04046)) WERE SELECTED AS RELATED TO THE OCCLUSION / NO IRRIGATION ISSUE. 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 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A TRANSPARENT FOREIGN MATERIAL BLOCKING THE IRRIGATION HOLES. INITIALLY, IT WAS REPORTED THAT DURING PULMONARY VEIN ISOLATION (PVI), WHEN FLASHING, CHAR WAS SEEN IN THE TIP OF THE IRRIGATION HOLE AND NO WATER WAS COMING OUT. IT OCCURRED ONE HOUR AFTER CATHETER USE. THE CATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED. NO NEUROLOGICAL SYMPTOM OCCURRED SINCE THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE CHAR IS NOT MDR REPORTABLE. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY (RF) ENERGY DELIVERY AND CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR ON THE ELECTRODES DOES NOT REPRESENT A SERIOUS INJURY IN ITSELF, NOR IS IT NECESSARILY THE RESULT OF DEVICE MALFUNCTION. THE OCCLUSION/NO IRRIGATION IS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 12-APR-2023 THAT THERE WAS A TRANSPARENT FOREIGN MATERIAL BLOCKING THE IRRIGATION HOLES.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
    688207 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 30916839L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown JPN CARTO 3 SYSTEM.| THMCL SMTCH SF BID, TC, D-D.| UNK OPTICAL DVI CABLE.| UNK OPTICAL DVI CABLE.