BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20691183 · Received November 14, 2024

    Report

    Report Number
    2029046-2024-03679
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 18-NOV-2024. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER, INC. PRODUCTS. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE FLOW SETTING WAS 8ML-15ML. ADDITIONAL INFORMATION WAS RECEIVED ON 21-NOV-2024. THE CORONARY SINUS (CS) CATHETER USED WAS JLL, BEEAT (6F, 20P). THEREFORE, UPDATED THE CONCOMITANT PRODUCT OF UNK CORONARY SINUS CATHETER TO JLL, BEEAT CS (6F, 20P) CATHETER UNDER THE D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES SECTION. ADDITIONAL INFORMATION WAS RECEIVED ON 25-NOV-2024. ACT WAS AROUND 300. CATHETER SETTINGS WERE CORRECTLY SELECTED. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. PATIENT FULLY RECOVERED. IN ADDITION, PROVIDED ADDITIONAL CONCOMITANT PRODUCTS. THEREFORE, UPDATED D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES SECTION. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 02-DEC-2024. THE DEVICE EVALUATION WAS COMPLETED ON 10-DEC-2024. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J MEDTECH 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 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. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, 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 PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF JOHNSON & JOHNSON MEDTECH¿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

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, WHEN THE CORONARY SINUS (CS) CATHETER WAS REMOVED AND THE PACING WAS STOPPED, IT WAS CONFIRMED THAT BLOOD PRESSURE HAD DROPPED AND EFFUSION HAD OCCURRED. THE ISSUE WAS RESOLVED BY ADDING MEDICATION AND PERFORMING DRAINAGE. A BLOOD TRANSFUSION WAS SCHEDULED TO BE PERFORMED IN THE INTENSIVE CARE UNIT (ICU). PATIENT REQUIRED EXTENDED HOSPITALIZATION. ATRIAL SEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED BEFORE TAMPONADE WAS CONFIRMED. THE PHYSICIAN¿S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND PRODUCT WAS THAT THE BLOOD DATA SATURATION ALSO SUGGESTS THAT IT WAS LIKELY TO BE VENOUS BLOOD RATHER THAN ARTERIAL BLOOD IN THE LEFT ATRIUM, AND THAT IT MIGHT HAVE OCCURRED AT THE TIME OF CS CATHETER PLACEMENT. STEAM POP WAS NOT CONFIRMED. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN¿S OPINION OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. PATIENT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350670 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31347846L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H| L JLL, BEEAT CS (6F, 20P) CATHETER| OCTA,LNG,48P,3-3-3-3-3,D-CURVE| SMARTABLATE GEN. KIT (JAPAN)| SMARTABLATE PUMP KIT (JAPAN)| SOUNDSTAR ECO SMS 8F CATHETER| UNK CORONARY SINUS CATHETER| UNK_CARTO 3| UNK_TRANSEPTAL NEEDLE