BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18484011 · Received January 10, 2024

    Report

    Report Number
    2029046-2024-00124
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    November 20, 2023
    Report Date
    July 16, 2024
    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

    EXTERNAL REFERENCE: (B)(4). INFORMATION WAS UPDATED ON THE DATABASE 19-JUN-2024. THE ADVERSE EVENT VALUE OF "UNEXPECTED/UNANTICIPATED" HAS BEEN CHANGED TO "EXPECTED/ANTICIPATED". CORRECTION: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. 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 · 0

    A 1. PATIENT IDENTIFIER: (B)(6). E 1. INITIAL REPORTER ADDRESS LINE 1(CONT.): 1ER SALLE 5 EJ AVENUE MAGELLAN, 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).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE PATIENT¿S MEDICAL HISTORY WAS PROVIDED. THEREFORE, B 7. MEDICAL HISTORY/PREEXISTING CONDITION HAS BEEN UPDATED. ON (B)(6) 2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. 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 (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31134044L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. BASED ON THE COMPLETED MRE, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. 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 WAS TO RECEIVE AN INDEX CARDIAC ABLATION FOR ATRIAL FIBRILLATION (AFIB) ON 20-NOV-2023. ON 20-NOV-2023, PATIENT EXPERIENCED INFERIOR ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) (AE1) CATEGORIZED AS SEVERE AND SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT DEFINED BY IN-PATIENT OR PROLONGED HOSPITALIZATION WITH ADMISSION OF (B)(6) 2023 AND DISCHARGE (B)(6) 2023. ALSO DEFINED BY MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED TO STUDY DEVICES AND RELATIONSHIP TO PRIMARY STUDY PROCEDURE IS PROBABLE TO THE INDEX PROCEDURE. THE SERIOUS AND RELATED EVENT IS CATEGORIZED AS UNEXPECTED/UNANTICIPATED. THE OUTCOME IS RECOVERED/RESOLVED. INTERVENTIONS REQUIRED WERE THROMBECTOMY, PRE-DILATATION AND STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988055 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31134044L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R AGILIS SHEATH| OCTA,LNG,48P,3-3-3-3-3,F-CURVE| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR