BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17280219 · Received July 7, 2023

    Report

    Report Number
    2029046-2023-01462
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 8, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12-JUL-2023. IT WAS REPORTED THAT THE GENERATOR PARAMETERS WERE POWER CONTROL MODE. THE THROMBUS WAS LOCATED ON THE TIP ELECTRODE. NO ERROR MESSAGES NOR PRODUCT PROBLEMS WERE REPORTED. NO PICTURE WAS AVAILABLE. THERE WAS NO PATIENT EFFECT. A SMARTABLATE GENERATOR WAS USED. THEREFORE, THE CONCOMITANT PRODUCT SECTION WAS UPDATED ON THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW ON 09-AUG-2023, IT WAS NOTED THAT THE H6.MEDICAL DEVICE PROBLEM CODE OF HIGH READINGS (A090807) DOES NOT APPLY TO THE REPORTED EVENT. THE CUSTOMER REPORTED THE IMPEDANCE INCREASED. AS SUCH, THIS IS ONLY A READING IN THIS SCENARIO AND DOES NOT INDICATE A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31033709L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED THROMBOSIS. IT WAS REPORTED THAT DURING THE ABLATION OF LEFT INFERIOR PULMONARY VEIN (LIPV), THE IMPEDANCE INCREASED, AND INTRACARDIAC THROMBUS WAS FOUND ADHERED BY CHECKING WITH AN ECHO CATHETER. TIMING WAS TWENTY MINUTES AFTER THE START OF PULMONARY VEIN ISOLATION (PVI), DURING THE ABLATION OF LIPV. THE PROBLEM WAS RESOLVED BY ASPIRATING THE THROMBUS THROUGH AN AGILIS SHEATH. AFTER THAT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE OCCURRENCE WAS NOTICED DURING THE IMPEDANCE CHANGE. THERE WAS NO IRRIGATION FAILURE. THE ABLATION TIME WAS NOT LONGER THAN 60 SECONDS (PER ONE ABLATION). THE ABLATION TIME WAS NOT LONGER THAN 120 SECONDS (PER ONE ABLATION). THE AVERAGE CONTACT FORCE (CF) VALUE EXCEEDED 25G. THE AVERAGE CF VALUE DID NOT EXCEED 40G. THE IRRIGATION SETTING WAS WITHIN THE SPECIFIED RANGE. THE THROMBUS ADHERED TO THE INTRACARDIAC WALL. THE POWER WAS 50W. THE HIGH IMPEDANCE WAS ASSESSED AS NOT MDR REPORTABLE. SINCE THE USER-DEFINED CUT-OFF WAS NOT EXCEEDED, THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN A 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 AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421467 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 31033709L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening UNK AGILIS SHEATH| UNK_SMARTABLATE GENERATOR