BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20195802 · Received September 11, 2024

    Report

    Report Number
    2029046-2024-03037
    Event Type
    Death
    Date Received
    September 11, 2024
    Date of Event
    February 7, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).

    Additional Manufacturer Narrative · 0

    ON 13-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS INDICATED THAT NO ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED TO BE MDR REPORTABLE AGAINST THE THERMOCOOL SMARTTOUCH SF CATHETER. HOWEVER, SINCE A PENTARAY NAV WAS REPORTED TO HAVE BEEN USED, THE EVENT HAS BEEN REASSESSED AND IS NOW CONSIDERED MDR REPORTABLE AGAINST THE MAPPING CATHETER. THE AWARENESS DATE IS 13-NOV-2024. AS SUCH, THE H6. HEALTH EFFECT - CLINICAL CODE, H6. HEALTH EFFECT - IMPACT CODE, AND H6. MEDICAL DEVICE PROBLEM CODE HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) PROCEDURE AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. CARDIAC SURGERY WAS PLANNED; HOWEVER, THE PATIENT DIED PRIOR TO GETTING SURGERY. DURING THE PVI PROCEDURE, THERE WAS A DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION WAS DETECTED VIA ULTRASOUND. ASPIRATION OF FLUID FROM THE PERICARDIUM WAS DONE. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO NEAREST CARDIAC SURGERY; HOWEVER, THE PATIENT DIED DURING TRANSPORT. THE PHYSICIAN'S OPINION ON THE ADVERSE EVENT WAS HUMAN FAILURE. THERE WERE NO PROBLEMS WITH THE MAPPING-SYSTEM OR CATHETERS. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515836 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| D| H 6FR CS,F,10 POLE,12 PIN,AUTOID| 8.5F SHEATH WITH CURVE VIZ MDC| ABBOTT BRK NEEDLE| PENTARAY NAV ECO 7FR, F, 2-6-2| SMARTABLATE GENERATOR KIT-WW| UNK_CARTO 3