BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15975098 · Received December 14, 2022

    Report

    Report Number
    2029046-2022-03097
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 14, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. SECTION H3. HAS BEEN UPDATED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 MALE PATIENT WEIGHING 335 LBS. UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING AN AFIB ABLATION PROCEDURE THERE WAS A DROP IN PRESSURE ON THE "ULTRASOUND SYSTEM". WHEN INVESTIGATED, A PERICARDIAL EFFUSION (PE) WAS REVEALED USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) ULTRASOUND CATHETER. TO INTERVENE, A PERICARDIOCENTESIS WAS USED AND DRAINED "2800" FROM THE PATIENT HOWEVER THEY WERE ABLE TO "GIVE THE SAME AMOUNT BACK TO THE PATIENT". THE PATIENT HAS SINCE STABILIZED BUT THE EFFUSION HAS NOT GONE AWAY. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS IT WAS PRODUCT RELATED AS PERFORATION OCCURRED WITH THE ABLATION CATHETER. THE PATIENT WAS STABLE AND WAS WALKING AT THE TIME OF THE CALL. INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND PERICARDIAL WINDOW. THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT FOR OBSERVATION. RELEVANT TESTS/LABORATORY DATA-HEMO 8.6, HEMATOCRIT 26.2, RBD 2.99, WBC 8.2, PLT 220 (AS OF 11/21). OTHER RELEVANT HISTORY-CHRONIC AF, CONGESTIVE HEART FAILURE, DIABETIC, HIGH BLOOD PRESSURE, LYMPHEDEMA, OBESE, FORMER SMOKER. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS NRG NEEDLE. ABLATION WAS PERFORMED PRIOR TO NOTING THE PE OR CT. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING ABLATION. THE FLOW SETTING FOR THE IRRIGATED CATHETER USED WAS LOW FLOW. CORRECT CATHETER SETTINGS WAS SELECTED ON THE GENERATOR. PUMP SWITCHING WAS FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR, AND VISITAG. PARAMETERS FOR STABILITY FOR THE VISITAG MODULE USED WAS RANGE: 2MM; TIME: 3; FOT: 25%; TAG SIZE: 3. NO ADDITIONAL FILTER USED WITH THE VISITAG. COLOR OPTIONS USED PROSPECTIVELY WAS FTI. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455787 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30898111L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| L SMARTABLATE GENERATOR SPARE-US| UNK BAYLIS NRG NEEDLE| UNK_CARTO 3