BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18691179 · Received February 12, 2024

    Report

    Report Number
    2029046-2024-00471
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 12, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, 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 31169998L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. E1. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. AFTER PULMONARY VEIN ISOLATION (PVI) AND CAVOTRICUSPID ISHMUS (CTI), THE PROCEDURE WAS COMPLETED AND PERICARDIAL EFFUSION WAS CONFIRMED WHILE CHECKING WITH SOUND STAR ECO CATHETER FROM THE RIGHT ATRIUM. AFTERWARDS, BLOOD PRESSURE GRADUALLY DECREASED FROM 110/78 TO 71/59, AND SPO2 REMAINED UNCHANGED AT 100%. DRAINAGE OF THE PERICARDIAL FLUID WAS PERFORMED AND THE PROCEDURE WAS FINISHED. THIS EVENT WAS NOT RELATED TO THE PRODUCT DEFECT. NO ABNORMALITIES OBSERVED BEFORE OR DURING USE OF THE PRODUCT. THE PHYSICIAN¿S DECISION OF THE HEALTH PROBLEM IS THAT IT WAS ¿SERIOUS¿. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT HOSPITALIZATION WAS EXTENDED FOR 1 DAY BECAUSE OF THE OBSERVATION AFTER DRAINAGE TO CARDIAC TAMPONADE. PATIENT FULLY RECOVERED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE. NO STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306298 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31169998L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| R| H NGEN RF GENERATOR, JAPAN| OCTA,LNG,48P,2-5-2-5-2,D-CURVE| SOUNDSTAR ECO SMS 8F CATHETER| UNKNOWN TRANSSEPTAL NEEDLE| UNK_CARTO 3