BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16376004 · Received February 14, 2023

    Report

    Report Number
    2029046-2023-00297
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 17, 2023
    Report Date
    March 29, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AVAILABLE INFORMATION 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 30821719M NUMBER, AND NO INTERNAL ACTIONS 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. INITIAL REPORTER PHONE: (B)(6). 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

    ON 2-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INVESTIGATORS OPINION ON THE ADVERSE EVENT WAS UPDATED FROM ¿UNEXPECTED/UNANTICIPATED¿ TO ¿EXPECTED/ANTICIPATED¿. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    DURING A CLINICAL TRIAL, SPONSORED BY BWI, IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CONTROLLED CLASS I CONGESTIVE HEART FAILURE AND NON-ISCHEMIC CARDIOMYOPATHY UNDERWENT AN INDEX CARDIAC ATRIAL FIBRILLATION (A-FIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER ON (B)(6) 2023 UNDER GENERAL ANESTHESIA AND EXPERIENCED BLADDER PARALYSIS REQUIRING PROLONGED HOSPITALIZATION. IT WAS REPORTED THE PATIENT CHA2DS2-VASC SCORE WAS 2. ESOPHAGEAL MONITORING WAS PERFORMED WITH MULTI-ELECTRODE TEMPERATURE PROBE WITH CUT-OFF SETTING OF 40 DEGREES CELSIUS. PATIENT¿S HISTORY INCLUDES PRE-PROCEDURE CARDIOVERSION ON (B)(6) 2022. ON SAME DAY OF INDEX PROCEDURE ON (B)(6) 2023, PATIENT IS NOTED WITH BLADDER PARALYSIS CATEGORIZED AS NOT RELATED TO THE STUDY DEVICE BUT CAUSAL RELATIONSHIP WITH THE PROCEDURE. PI CATEGORIZED THIS ADVERSE EVENT AS MILD IN SEVERITY, SERIOUS DUE TO IN-PATIENT PROLONGED HOSPITALIZATION. THE EVENT WAS REPORTED AS UNEXPECTED/UNANTICIPATED. PATIENT DID NOT DIE. PATIENT OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. NO INTERVENTION WAS PROVIDED. PATIENT DISCHARGED NEXT DAY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556308 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 30821719M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization AGILIS SHEATH| CARTO 3 SYSTEM| NGEN RF GENERATOR| PENTARAY NAV ECO 7FR, D, 2-6-2