BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15786300 · Received November 13, 2022

    Report

    Report Number
    2029046-2022-02817
    Event Type
    Injury
    Date Received
    November 13, 2022
    Date of Event
    September 28, 2022
    Report Date
    February 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 30678773L 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).

    Additional Manufacturer Narrative · 0

    ON 25-JAN-2023, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE CARTO 3 SYSTEM WAS IN USE. THE PRODUCT HAS ALSO BEEN ADDED TO THE CONCOMITANT PRODUCTS SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) WHILE THE INITIAL REPORT MENTIONED PROLONGED HOSPITALIZATION, THE B2 CHECKMARK FOR HOSPITALIZATION INITIAL/PROLONGED WAS MISTAKENLY OMITTED AND HAS NOW BEEN SELECTED.

    Description of Event or Problem · 0

    DURING A BWI CLINICAL STUDY, IT WAS REPORTED THAT A 72-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2022 WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED AN INFLAMMATORY PERICARDIAL EFFUSION. PER THE STUDY INVESTIGATOR THE ADVERSE EVENT SEVERITY IS MODERATE, AND IT IS SERIOUS AND THE PATIENT DID NOT DIE. THE EVENT IS BOTH SERIOUS AND PROCEDURE RELATED, AND NOT EXPECTED/ANTICIPATED IN THE OPINION OF THE INVESTIGATOR. THERE WAS A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AND IT WAS NOT CONSIDERED A LIFE-THREATENING ILLNESS OR INJURY. NO PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES. IN-PATIENT OR PROLONGATION HOSPITALIZATION WAS REQUIRED FROM (B)(6) 2022. MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION WAS REQUIRED. RELATIONSHIP TO STUDY DEVICE OCTARAY:D160906: NOT RELATED. RELATIONSHIP TO STUDY DEVICE THERMOCOOL SMARTTOUCH: NOT RELATED. RELATIONSHIP TO STUDY DEVICE INDEX: SHEATH: AGILIS: NOT RELATED. PER THE STUDY INVESTIGATOR THE RELATIONSHIP TO STUDY PROCEDURE: CAUSAL, THE EVENT IS RELATED TO THE INDEX PROCEDURE, AND THE ADVERSE EVENT IS CONSIDERED EXPECTED/ANTICIPATED. THERE WAS INTERVENTION/ TREATMENT. MEDICATION WAS GIVEN. NO CARDIOVERSION WAS PERFORMED. IT WAS NOT A RE-ABLATION PROCEDURE. NO SURGERY WAS PERFORMED. OTHER INTERVENTION PROVIDED WAS PERICARDIAL PUNCTURE. OUTCOME: RECOVERED/RESOLVED. 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 AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356049 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30787685L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R| L AGILIS SHEATH| CARTO 3 SYSTEM| OCTARAY