BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19813357 · Received July 23, 2024

    Report

    Report Number
    2029046-2024-02485
    Event Type
    Injury
    Date Received
    July 23, 2024
    Report Date
    August 17, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION WAS RECEIVED ON 24-JUL-2024 STATING HLR REPORTED IN THE 3500A INITIAL IS HEART-LUNG-RESCUE MEANING CARDIOPULMONARY RESUSCITATION. THEREFORE, ADDED H6. HEALTH EFFECT - CLINICAL CODE OF "CARDIAC ARREST (E0602)*. THE INVESTIGATION WAS COMPLETED ON 28-JUL-2024. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF 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 A CARDIAC ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AN EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANAESTHETIC AND STARTED SHOWING SIGNS OF TAMPONADE. BLOOD PRESSURE (BP) WAS DROPPING AND ECO SHOWED PERICARDIAL EFFUSION. "HLR" WAS PERFORMED AND THE EFFUSION WAS DRAINED WITH IMPROVEMENT IS THE PATIENTS VITAL PARAMETERS. THE PATIENT RECOVERED ENOUGH TO BE MOVED TO THE NORMAL WARD. AT THE TIME OF THE EVENT THERE VERY NO SIGNS OF ANYTHING BEING WRONG. HOWEVER, IN THE BEGINNING OF THE PROCEDURE, THE TRANSEPTAL PUNCTURE WAS PERFORMED. THE PHYSICIAN OBSERVED THAT THE WIRE WENT INTO THE PERICARDIUM. HE THEN QUICKLY RETREATED THE WIRE AND NO OTHER MEASUREMENTS VERY TAKEN AT THE TIME. IT IS THE PHYSICIAN¿S OPINION THAT THE EFFUSION HAS BEEN SLOWLY DEVELOPING SINCE THEN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371367 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L UNK_CARTO 3.| UNK_NGEN RF GENERATOR.