BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17597901 · Received August 22, 2023

    Report

    Report Number
    2029046-2023-01830
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31072090L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A PATIENT RECEIVED A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED A HEARTBLOCK AV. IT WAS REPORTED BY THE CALLER THAT AFTER MANIPULATING THE STSF ABLATION CATHETER IN THE LEFT VENTRICLE AND APPLYING RADIOFREQUENCY (RF), AV HEART BLOCK WAS NOTED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM ELECTROGRAMS (THIS WAS NOTED AFTER REVIEWING ELECTROGRAMS POST-ABLATION). THE MEDICAL TEAM STATED THAT THERE WERE NO INDICATIONS OF CONDUCTION SYSTEM DEFLECTIONS ON THE ABLATION CATHETER ELECTROGRAMS RIGHT BEFORE ABLATING. THE PATIENT IS CURRENTLY STABLE. ADVERSE EVENT DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE ISSUE- MAY HAVE BEEN PRESSURE FROM THE ABLATION CATHETER TIP THAT SUPPRESSED THE CONDUCTION SYSTEM RIGHT BEFORE RF WAS APPLIED. AS AN INTERVENTION TO THE ADVERSE EVENT, REPORTER THINKS A PERMANENT PACEMAKER WAS IMPLANTED BUT IS NOT SURE. PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING MAPPING/ABLATION STAGE. IRRIGATED CATHETER WAS USED IN THE EVENT AND FLOW SETTING WAS 8/15 ML PER INSTRUCTIONS FOR USE (IFU). NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. PATIENT IS HEMODYNAMICALLY STABLE AT THIS TIME. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300891 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31072090L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H CARTO 3 SYSTEM| SOUNDSTAR CATHETER