BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15999629 · Received December 16, 2022

    Report

    Report Number
    2029046-2022-03157
    Event Type
    Death
    Date Received
    December 16, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 25, 2023
    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. CATALOG IS "UNK_SMART TOUCH BIDIRECTIONAL SF" (THE ABLATION CATHETER INFORMATION WAS NOT PROVIDED, AS SUCH, THE EVENT IS BEING CONSERVATIVELY REPORTED AGAINST A BWI ABLATION CATHETER. ADDITIONAL FOLLOW UP FOR PRODUCT INFORMATION IS BEING PERFORMED). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 30-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE PRODUCT DETAILS OF THE ABLATION CATHETER. THE PRODUCT CODE AND LOT NUMBER WERE PROVIDED AND ALL APPROPRIATE FIELDS HAVE BEEN UPDATED. D4. CATALOG, D4. LOT, D4. EXPIRATION DATE, D4. UNIQUE IDENTIFIER (UDI) G4. PMA/ 510(K) AND H4. DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. ADDITIONALLY, IT WAS REPORTED THE DEVICE IS NOT AVAILABLE FOR RETURN. DEVICE INVESTIGATION DETAILS: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30892874L NUMBER, 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (ABLATION CATHETER) AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING A PVC PROCEDURE THE PHYSICIAN NOTICED A CARDIAC EFFUSION. THE PHYSICIAN WAS ABLE TO CONFIRM THE INJURY WITH THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) ULTRASOUND SYSTEM VIA THE SOUNDSTAR CATHETER. PERICARDIOCENTESIS WAS UTILIZED TO INTERVENE WITH THE INJURY AND 1200 ML OF FLUID WAS REMOVED FROM THE PATIENT. "THE PHYSICIAN BELIEVES THAT HE MAY HAVE PERFORATED THE SEPTUM WITH THE ABLATION CATHETER" WHICH CAUSED THE INJURY. THE PATIENT HAS PASSED AWAY ON (B)(6) 2022 IN THE LAB. IN THE PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS THE PATIENT¿S CONDITION AND THE PVC ABLATION IN RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AS PATIENT DEVELOPED THE CARDIAC TAMPONADE. NO TRANSSEPTAL PUNCTURE PERFORMED. NO EVIDENCE OF STEAM POP. EVENT OCCURRED DURING THE ABLATION PHASE. THE FLOW SETTING FOR THE IRRIGATED CATHETER USED WAS THE STANDARD SETTING. CORRECT CATHETER SETTINGS WAS SELECTED ON THE SMARTABLATE GENERATOR AND THE PUMP SWITCHING WAS NOT 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 WERE RANGE: 2.5, TIME: 3, FORCE OVER TIME (FOT) 3 AND 25%, TAG SIZE OF 3. ADDITIONAL FILTER USED WAS RESPIRATORY GATED. COLOR OPTIONS USED PROSPECTIVELY WAS FORCE TIME INTERVEL (FTI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097742 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30892874L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death| R CARTO 3 SYSTEM.| SMARTABLATE GENERATOR SPARE-US.| SOUNDSTAR ECO GE 8F CATHETER.| UNKNOWN PUMP.