BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15154551 · Received August 3, 2022

    Report

    Report Number
    2029046-2022-01774
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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

    THE DEVICE EVALUATION WAS COMPLETED ON 31-AUG-2022. IT WAS REPORTED THAT A 41-YEAR-OLD MALE PATIENT (113KG) UNDERWENT AN ATRIOVENTRICULAR RE-ENTRY TACHYCARDIA (AVRT) AND A WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE AND ST ELEVATIONS REQUIRING PERICARDIOCENTESIS. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND AN EVALUATION OF ALL FEATURES OF THE DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT NO DAMAGE OR ANOMALIES ON THE DEVICE. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, ELECTRICAL, TEMPERATURE AND FORCE FEATURES WERE TESTED AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING AND IRRIGATING CORRECTLY. NO MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 05-AUG-2022. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 41-YEAR-OLD MALE PATIENT (113KG) UNDERWENT AN ATRIOVENTRICULAR RE-ENTRY TACHYCARDIA (AVRT) AND A WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE AND ST ELEVATIONS REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT ABOUT MID-CASE THERE WAS MILD ST ELEVATION. THEY CONTINUED WITH THE CASE, AND THEY HAD TO PACE THE VENTRICLE REALLY FAST IN ORDER TO ALLOW FOR PATHWAY CONDUCTION. AFTER PACING FURTHER, THE ST ELEVATION PROCEEDED TO GET WORSE. AFTER VENTRICULAR PACING, THEY STOPPED FOR A PERIOD OF TIME AND THE ST ELEVATIONS GOT BETTER. THEY GOT TRANSEPTAL ACCESS AND IT WAS NOTED THAT THE PATIENT HAD A SMALL PERICARDIAL EFFUSION DURING TRANSEPTAL ACCESS. THEY BEGAN MAPPING IN THE LEFT ATRIUM, THEY MAPPED THE PATHWAY AND THEN ANESTHESIA NOTED THE PATIENT'S BLOOD PRESSURE DROPPED. THE ICE CATHETER SHOWED THE EFFUSION HAD GOTTEN WORSE. THEY QUICKLY ABLATED THE PATHWAY, AND A FEW SMALL LESIONS WERE ABLATED, THE BLOOD PRESSURE CONTINUED TO DROP. A PERICARDIOCENTESIS WAS DONE AND 580 ML OF FLUID WAS REMOVED. THE PATIENT THEN BECAME STABLE. THE PATIENT DID NOT REQUIRE SURGICAL REPAIR. THE PATIENT WAS THEN STABILIZED, AND THE ICE CATHETER CONFIRMED THE EFFUSION WAS CLEARED. THE PATIENT IS STAYING OVERNIGHT FOR OBSERVATION. THE PHYSICIAN FELT THE TRANSEPTAL ACCESS MAY HAVE CAUSED THE EFFUSION. THEY USED A TOTAL OF 35 WATTS. ADDITIONAL INFORMATION WAS RECEIVED.. THE PHYSICIAN FEELS THE EFFUSION HAPPENED AT SOME POINT DURING THE TRANSSEPTAL PORTION OF THE PROCEDURE. THE EFFUSION WASN'T NOTED UNTIL AFTER WE WERE LEFT SIDED. THE ST ELEVATION WAS MOST CERTAINLY DUE TO THE VENTRICULAR PACING THAT WAS REQUIRED TO MAP THE ACCESSORY PATHWAY. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED, NO ISSUES. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN TS NEEDLE. ABLATION WAS PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. THERE WAS NO EVIDENCE OF STEAM POP. THE CARDIAC TAMPONADE WAS NOTED DURING THE ABLATION PHASE OF A CONCEALED ACCESSORY PATHWAY. THE IRRIGATION CATHETER WAS USED AND THE FLOW SETTING WAS NORMAL, 2ML SLOW, 15ML FAST. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR & VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY 3 MM, 3 SEC, 25% @ 3 GRAMS OF FORCE, 2 MM WITH IMPEDANCE DROP WAS USED FOR COLORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553908 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30795345L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention| L NON BWI-HEARTSPAN TRANSSEPTAL NEEDLE.| SMARTABLATE GENERATOR KIT-US.| UNKNOWN BRAND ICE CATHETER.| UNKNOWN BRAND PUMP.| UNK_CARTO 3.