BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18410448 · Received December 28, 2023

    Report

    Report Number
    2029046-2023-03100
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED PULMONARY EDEMA THAT REQUIRED SUPPLEMENTAL OXYGEN THERAPY. THE PATIENT SUFFERED POSSIBLE PULMONARY EDEMA. AFTER THE PROCEDURE, THE PATIENT HAD DIFFICULTY BREATHING AND WAS COUGHING UP PHLEGM. THE PATIENT HAD SOME DIFFICULTY BREATHING BEFORE THE PROCEDURE AS WELL. THE PULMONARY EDEMA WAS UNABLE TO BE CONFIRMED. NO MEDICAL INTERVENTION WAS PROVIDED BUT RESPIRATORY RAPID RESPONSE TEAM WAS CALLED, AND THEY PROVIDED OXYGEN TO THE PATIENT (OXYGEN MASK AND BAG) BEFORE TRANSFERRING THE PATIENT TO THE RECOVERY ROOM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS RESTING. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PATIENT¿S CONDITION. THE PHYSICIAN DISCUSSED THAT THE PATIENT WAS DOING BETTER AFTER SHE WAS TRANSFERRED TO THE RECOVERY ROOM. HE SAID THE TOTAL FLUID WAS MINIMAL FOR THE PROCEDURE (ABOUT 400 ML WITH 250 ML COMING FROM THE IRRIGATED CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266586 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SMARTABLATE GENERATOR KIT-US.