BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21684857 · Received March 24, 2025

    Report

    Report Number
    2029046-2025-00898
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 25-MAR-2025. RESULTS OF THE ANGIOGRAM WAS A BLOOD FLOW CONGESTION OF THE RADIAL ARTERY WHICH LED TO THE ASSUMPTION THAT IT COULD HAVE BEEN A THROMBUS OF THE RADIAL ARTERY. THE ROOT CAUSE OF THE CHEST PAIN AND THE ST ELEVATION SEEMED TO BE A TEMPORARY THROMBUS OF A CORONARY ARTERY. AFTER THE APPLICATION OF HEPARIN, IT WAS NO LONGER VISIBLE IN THE ANGIOGRAM AND THE CHEST PAIN WAS GONE. THE PATIENT'S WRIST WEAKNESS / NO RADIAL PULSE WAS BEFORE THE ANGIOGRAPHY AND RADIAL ACCESS IN THE SAME WRIST WAS NOT USED FOR THE ANGIOGRAM. THEREFORE, ASSESSED TO ADD UNDER H 6. HEALTH EFFECT - CLINICAL CODE ¿THROMBOSIS/THROMBUS (E0514)¿. THE DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED ST ELEVATION, CHEST PAIN THAT REQUIRED ANGIOGRAM. THE PATIENT ALSO HAD NO RADIALIS PULSE AND WRIST WEAKNESS THAT REQUIRED MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION ON 31-MAR-2025. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J 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, OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED ST ELEVATION, CHEST PAIN THAT REQUIRED ANGIOGRAM. THE PATIENT ALSO HAD NO RADIALIS PULSE AND WRIST WEAKNESS THAT REQUIRED MEDICAL INTERVENTION. ADVERSE EVENT HAPPENED 30 MINUTES AFTER A PROCEDURE WITH BIOSENSE WEBSTER PRODUCTS. THE PATIENT HAD ST ELEVATIONS, CHEST PAIN AND WRIST WEAKNESS/ NO RADIALIS PULSE. PATIENT HAD AN ANGIOGRAPHY AND APPLICATION OF HEPARIN AND TREATMENT WITH AN ACTILYSE PERFUSOR. AFTER AN APPLICATION OF HEPARIN, THE ST ELEVATIONS WERE NO LONGER THERE, AND THE PATIENT DID NOT HAVE CHEST PAIN ANYMORE. THE PATIENT STILL HAD NO RADIALS PULSE. THE PATIENT WAS TREATED WITH AN ACTILYSE PERFUSOR. THE PATIENT WILL HAVE IT OVER NIGHT WITH CONTINUOUS MONITORING. THE PATIENT WAS NO LONGER ON THE TABLE. PROCEDURE WAS AN ABLATION IN THE ANTERIOR LEFT VENTRICULAR OUTFLOW TRACT - (LVOT). THE APPROACH TO REACH THE LVOT WAS RETROAORTIC. THE PHYSICIANS GAVE 9000 HEPARIN IN TOTAL DURING THE PROCEDURE, ACT LEVEL WAS 362. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081557 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31464994L 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| H 6FR CS,F,10 POLE,12 PIN,AUTOID| NGEN PUMP, EU CONFIGURATION| NGEN RF GENERATOR