BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15993812 · Received December 16, 2022

    Report

    Report Number
    2029046-2022-03150
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 16, 2022
    Report Date
    November 6, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). 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. 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

    ON 6-NOV-2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 UNDERWENT AN UNKNOWN ABLATION PROCEDURE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. THE PROCEDURE WAS A PULMONARY VEIN ISOLATION USING CARTO WITH OCTARAY TO MAP THE LEFT ATRIUM AND THE FARAPULSE PFA ABLATION SYSTEM TO ISOLATE THE VEINS. AFTER THE ABLATION WITH THE FARAPULSE WAS FINISHED IN THE LEFT ATRIUM THE PATIENT DEVELOPED RIGHT ATRIAL FLUTTER AND THE FLUTTER WAS ABLATED USING THE FARAPULSE. DURING THE PROCEDURE THE PATIENTS BLOOD PRESSURE HAD FALLEN AND IT WAS FOUND THAT THE PATIENT HAD AN PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS THEN PERFORMED AND THE PATIENTS BLOOD PRESSURE RECOVERED. THE PATIENT LEFT THE CATH LAB TO BE MONITORED IN THE ICU. THE ADVERSE EVENT WAS DISCOVERED DURING THE USE OF BIOSENSE PRODUCTS. THE PHYSICIAN DID NOT GIVE AN OPINION OF THE CAUSE OF THE ADVERSE EVENT. THE PATIENT HAD TO UNDERGO A PERICARDIOCENTESIS TO DRAIN THE BLOOD. OUTCOME OF THE ADVERSE EVENT-FULLY RECOVERED (NO RESIDUAL EFFECTS)/ THE PATIENT HAD TO BE TRANSFERRED TO THE ICU AS THE PATIENT STILL HAD A PERICARDIAL EFFUSION WHEN THEY LEFT THE LAB. PATIENT GENDER-MALE. OTHER RELEVANT HISTORY-N/A. GENERATOR INFORMATION. MAKE, MODEL, SERIAL NUMBER- NGEN GENERATOR. REF: (B)(4) SN: (B)(4). A TRANSEPTAL PUNCTURE WAS PERFORMED, THE NEEDLE USED WAS AN ABBOTT BRK NEEDLE. NO EVIDENCE OF A STEAM POP. THE FLOW SETTINGS WERE THE STANDARD SF SETTINGS. 8ML/MIN FOR 30 WATTS AND BELOW AND 15ML/MIN FOR 30 WATTS AND ABOVE. THEY WERE ABLATING AT 35 WATTS. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP SWITCHING WAS FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THERE WERE NO ERRORS INDICATED. THERMOCOOL® SMARTTOUCH® SF CATHETER WAS USED. FORCE VISUALIZATION FEATURES USED WERE-GRAPH, DASHBOARD AND VECTOR. VISITAG WERE USED, THE SETTINGS WERE 3 SECS/3MM STABILITY/3 GRAMS FOR 25%. TAG SIZE WAS 3MM. TAG COLORS WERE BASED ON TIME. NO ADDITIONAL FILTER USED WITH THE VISITAG COLOR OPTIONS USED PROSPECTIVELY-TIME. 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
    2570652 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R ABBOTT BRK NEEDLE.| CARTO 3 SYSTEM.| CARTO VISITAG MODULE.| FARAPULSE PFA ABLATION SYSTEM.| NGEN GENERATOR.| OCTARAY CATHETER.