BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17111101 · Received June 12, 2023

    Report

    Report Number
    2029046-2023-01273
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 12, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

    Additional Manufacturer Narrative · 0

    ON 10-OCT-2023, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THE INITIAL REPORT INDICATED THAT THE END DATE OF THE ADVERSE EVENT WAS 15-MAY-2023. HOWEVER, NEW INFORMATION INDICATES THAT THE EVENT WAS RESOLVED ON 14-MAY-2023. ADDITIONALLY, THE EVENT WAS REPORTED TO HAVE BEEN RECOVERED/RESOLVED WITH SEQUELAE. THIS HAS BEEN CHANGED TO MERELY RECOVERED/RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) HYPERTENSION WAS ADDED TO SECTION B7 (AS IT WAS MISTAKENLY OMITTED IN THE MEDICAL HISTORY FIELD IN THE PRIOR REPORT). THE B5 HAS BEEN REFORMATTED FOR CLARITY. NO EVENT INFORMATION HAS BEEN CHANGED ASIDE FROM WHAT WAS INDICATED IN THE ADDITIONAL MANUFACTURER NARRATIVE IN THIS SUPPLEMENTAL REPORT. THE UPDATED EVENT SUMMARY IS AS FOLLOWS: DURING A CLINICAL TRIAL SPONSORED BY BWI, A PATIENT WAS TO RECEIVE A CARDIAC ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED INTRAPROCEDURAL SINUS-BRADYCARDIA REQUIRING SURGICAL INTERVENTION OF A PACEMAKER IMPLANTATION. ON (B)(6) 2023, PATIENT EXPERIENCED INTRAPROCEDURAL SINUSBRADYCARDIA WITH A START DATE OF (B)(6) 2023 AND END DATE OF (B)(6) 2023. THE ADVERSE EVENT WAS DETERMINED TO NOT BE RELATED TO THE STUDY DEVICE--IT WAS DETERMINED THAT THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE ITSELF RATHER THAN ANY OF THE DEVICES USED. THE ADVERSE EVENT WAS UNEXPECTED/UNANTICIPATED. THE EVENT WAS RESOLVED ONCE THE PATIENT RECEIVED A PACEMAKER. CLINICAL UNDERSTANDING IS THE PROCEDURE MAY HAVE STARTED WITH PUNCTURE ACCESS AND POSSIBLY MAPPING. NOT ENOUGH DETAILS ARE PROVIDED TO DETERMINE THE TIMING OF THE OCCURRENCE. FOR A CONSERVATIVE MEASURE, THE CARDIAC ABLATION CATHETER WILL CARRY THE CODES FOR THE ADVERSE EVENT AND IS CATEGORIZED AS REPORTABLE TO THE US FDA. THE PATIENT HAD A HISTORY OF HYPERTENSION.

    Description of Event or Problem · 0

    DURING A CLINICAL TRIAL SPONSORED BY BWI, A PATIENT WAS TO RECEIVE A CARDIAC ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED INTRAPROCEDURAL SINUS-BRADYCARDIA REQUIRING SURGICAL INTERVENTION OF A PACEMAKER IMPLANTATION. THE DATABASE DOES NOT PROVIDE WHAT PHASE THE ADVERSE EVENT OCCURRED. ON (B)(6) 2023, PATIENT EXPERIENCED INTRAPROCEDURAL SINUSBRADYCARDIA CATEGORIZED AS SEVERE AND SERIOUS DEFINED BY MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION WITH START DATE OF (B)(6) 2023 AND END DATE OF (B)(6) 2023. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO PRIMARY STUDY PROCEDURE IS CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE. THE ADVERSE EVENT IS UNEXPECTED/UNANTICIPATED. THE OUTCOME IS RECOVERED/RESOLVED WITH SEQUELAE. INTERVENTION WAS IMPLANTATION OF PASSAGERE PACE MAKER. CLINICIAN ASSESSMENT: THE DATABASE DOES NOT PROVIDE ABLATION PROCEDURE DETAILS. CLINICAL UNDERSTANDING IS THE PROCEDURE MAY HAVE STARTED WITH PUNCTURE ACCESS AND POSSIBLY MAPPING. NOT ENOUGH DETAILS ARE PROVIDED TO DETERMINE THE TIMING OF THE OCCURRENCE. FOR A CONSERVATIVE MEASURE, THE CARDIAC ABLATION CATHETER WILL CARRY THE CODES FOR THE ADVERSE EVENT AND IS CATEGORIZED AS REPORTABLE TO THE US FDA. THE PATIENT HAD A HISTORY OF HYPERTENSION. 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
    957276 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134701 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| L NGEN GENERATOR| PENTARAY CATHETER