BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22101942 · Received May 28, 2025

    Report

    Report Number
    2029046-2025-01731
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31522604L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS 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. 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 IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE (IDVT) PROCEDURE WITH A DECANAV CATHETER AND A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT SUFFERED A PERICARDIAL EFFUSION TREATED WITH A PERICARDIOCENTESIS. DURING A PROCEDURE, WHILE MAPPING IN THE RIGHT VENTRICLE WITH THE DECANAV CATHETER, THE PHYSICIAN NOTICED A SMALL EFFUSION. AFTER A FEW ABLATIONS, THE EFFUSION WAS GETTING BIGGER PER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER IMAGING AND THE PHYSICIAN ABANDONED THE ABLATION. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 100 CC OF FLUID WAS REMOVED. THE PATIENT IS IN A STABLE CONDITION. THE PHYSICIAN DID NOT KNOW HOW THE EFFUSION OCCURRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE DECANAV CATHETER AND A THERMOCOOL SMARTTOUCH SF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710690 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31522604L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L 7FR DECAN,11P,F,2.4MMLE,282MM,| 8.5F SHEATH WITH CURVE VIZ LGC| CARTO 3 SYSTEM| NGEN RF GENERATOR, US| STERILMED SOUNDSTAR CATHETER R10439011