BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11882824 · Received May 26, 2021

    Report

    Report Number
    2029046-2021-00817
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. INITIAL VISUAL ANALYSIS OBSERVED NO PHYSICAL DAMAGE. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IN ADDITION, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4)CORRECTION: ON (B)(6)2021 IT WAS NOTICED THAT THE CONCOMITANT MED. PRODUCT WERE INADVERTENTLY OMITTED FROM SECTION D10. CONCOMITANT MED PRODUCTS OF THE 3500A INITIAL MEDWATCH REPORT THAT WAS SUBMITTED. THE ITEMS HAVE NOW BEEN ADDED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH TWO (2) THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS (LOT # 30494805L) WHEREIN A LOSS OF ALL ECG SIGNALS OCCURRED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION AND ELECTRICAL EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. ELECTRICAL TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND NO ELECTRICAL ISSUES WERE DETECTED DURING THE ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30494805L LOT NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND. TO MINIMIZE ECG NOISE, THIS GUIDELINE SHOULD BE FOLLOWED: IT IS RECOMMENDED THAT THE OBSERVATION ROOM AND THE OPERATING ROOM BOTH BE CONNECTED TO A COMMON PROTECTIVE GROUND. DOING SO PREVENTS LEAKAGE CURRENT BETWEEN VARIOUS EP LAB EQUIPMENT AND NOISE ON ECG CHANNELS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE AS THE DEVICE PERFORMED WITHOUT ANY ELECTRICAL ISSUES. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4)

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-(B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2021-00818 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH TWO (2) THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS (LOT # 30494805L) WHEREIN A LOSS OF ALL ECG SIGNALS OCCURRED. DURING ABLATION WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER #1 (LOT # 30494805L), A SUDDEN CURRENT LEAKAGE WAS DETECTED. THE TEAM TRIED TO CHANGE THE CABLE, BUT THE ERROR DID NOT RESOLVE SO THEY CHANGED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER # 1 (LOT # 30494805L) FOR THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER # 2 (LOT # 30494805L). AFTER INSERTING THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER # 2 (LOT # 30494805L) HAD SIGNAL NOISE ERROR. ALL SIGNALS HAD NOISE; SO ABLATION WAS STOPPED. THE CABLE WAS CHANGED BUT THE SAME ISSUE OCCURRED. AT THAT POINT THE TEAM CHANGED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER # 2 (LOT # 30494805L) FOR ANOTHER CATHETER (TYPE UNSPECIFIED) AND THE PROCEDURE WENT WELL; SUCCESSFUL. THE ISSUE OF CURRENT LEAKAGE ERROR IS NOT CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION SINCE THIS ISSUE IS HIGHLY DETECTABLE AND REQUIRES ADJUSTING SYSTEM COMPONENTS TO CONTINUE WITH THE PROCEDURE. DEVICES MAY REQUIRE RESET OR REPLACING BUT CANNOT BE USED ON THE PATIENT. PATIENT SAFETY IS UNAFFECTED BY THIS ISSUE. THE ISSUE OF ECG SIGNAL LOSS IS CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION AND SINCE THIS ISSUE OCCURRED WITH TWO CATHETERS OF THE SAME KIND AND SAME LOT NUMBER, THE ISSUE OF SIGNAL LOSS WILL BE REPORTED AGAINST BOTH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS (LOT # 30494805L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782002 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30494805L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTO 3 SYSTEM| SOUNDSTAR ECO CABLE ASSY 10 FT| SOUNDSTAR ECO GE 8F CATHETER| THMCL SMTCH SF BID, TC, D-F| THMCL SMTCH SF BID, TC, D-F| UNKNOWN RECORDING SYSTEM