BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17753512 · Received September 15, 2023

    Report

    Report Number
    2029046-2023-02087
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 7, 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

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. 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

    THE DEVICE EVALUATION WAS COMPLETED ON 13-OCT-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31076153L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. BASED ON THE COMPLETED MRE, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE EVENT. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER OBTAINING SOUND CONTOURS AND PLACING THE CORONARY SINUS (CS) CATHETER, THE OPTRELL CATHETER WAS INSERTED. THE RIGHT ATRIUM (RA) WAS MAPPED, THEN THE CATHETER WAS MOVED TO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR PACE MAPPING. THE OPTRELL WAS REMOVED AND THE STSF ABLATION CATHETER WAS INSERTED FOR ADDITIONAL PACE MAPPING. AT THE TIME OF THE CALL, THE PATIENT WAS STABLE, NO ISSUES. TEN RADIOFREQUENCY (RF) APPLICATIONS WERE PERFORMED (11 VISITAGS). THE PHYSICIAN THEN STATED THAT THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER "FELL OUT" OF POSITION, INTO THE INFERIOR VENA CAVA (IVC). WHEN THE SOUNDSTAR WAS REPOSITIONED BACK INTO THE RA, A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT'S BLOOD PRESSURE WAS LOW. A PERICARDIOCENTESIS WAS PERFORMED WITH 995 ML FLUID REMOVED. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE STATED THAT THE PATIENT WAS "ALERT, AWAKE AND STABLE" WHEN THEY LEFT THE LAB. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE EVENT. THE PATIENT PROBABLY REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE PATIENT WAS TRANSFERRED TO CVR (CARDIOVASCULAR RECOVERY UNIT). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED POST ABLATION. IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS PER THE IFU, 8/15 ML. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. PATIENT WAS HEMODYNAMICALLY STABLE AT THE TIME OF THE CALL. THE EFFUSION WAS DISCOVERED/NOTICED VIA ICE IMAGING. THE TUBE WAS LEFT IN PLACE. THE PROCEDURE WAS ABANDONED AS THE CALLER WAS NOT SURE THEY HAD REACHED THE ABLATION ENDPOINT. THERE WAS NO EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE. OTHER RELEVANT HISTORY- THIS WAS A REDO PREMATURE VENTRICULAR CONTRACTIONS (PVC) ABLATION. GENERATOR INFORMATION WAS A NGEN GENERATOR, SERIAL #(B)(6), MODEL #D138402. FORCE VISUALIZATION FEATURES USED WAS DASHBOARD, VECTOR AND VISITAG. VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WAS MAX DISTANCE CHANGE 3MM, MINIMUM TIME 3, FORCE OVER TIME 25%, MINIMUM FORCE 3 GRAMS, TAG SIZE 3MM.RESPIRATORY GATING WAS ON. TAG INDEX WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315117 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31076153L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L| H BWI CORONARY SINUS (CS) CATHETER| NGEN RF GENERATOR, US| UNK_CARTO 3| UNK_CARTO VIZIGO SHEATH| UNK_OPTRELL MAPPING CATHETER| UNK_SOUNDSTAR