BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15495332 · Received September 27, 2022

    Report

    Report Number
    2029046-2022-02325
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 16-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) / WOLFF-PARKINSON WHITE SYNDROME (WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC PERFORATION REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THERE WAS A CASE WHERE AN ISSUE WITH A CATHETER PERFORATED THE HEART WALL. DURING THE CASE ON TUESDAY, (B)(6) 2022, WHEN THE PHYSICIAN WENT TRANSSEPTAL, THEY PERFORATED THE LEFT LATERAL PART OF THE HEART WITHOUT NOTICE. THEY MAPPED AND ABLATED A BIT, AND LATER NOTICED THAT THE BLOOD PRESSURE STARTED TO DROP. OTHER PHYSICIANS WERE CALLED IN, AND THEY REMOVED THE CATHETER AND THE SHEATH AND SURGICALLY CATHETERIZED THE AFFECTED AREA. THE QUALITY TEAM AT THE HOSPITAL CAME TO REMOVE THE CATHETER AND THEY WERE GOING TO DO THEIR INTERNAL INVESTIGATION AND CALL THE CATHETER IN AT THAT TIME. THE BWI REPRESENTATIVE STATED THAT AFTER THE SURGICAL INTERVENTION, THE PATIENT WAS IN STABLE CONDITION. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. BLOOD WAS DRAINED OFF EPICARDIAL SPACE. ONCE STABLE, SURGERY TO REMOVE CATHETER WHILE CLOSING HOLE. THE PATIENT FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT FOR MONITORING. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS NRG NEEDLE. PRIOR TO NOTING THE CARDIAC PERFORATION, ABLATION WAS PERFORMED AND THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT WAS NOTICED DURING ABLATION. POSSIBLY OCCURRED DURING MAPPING PHASE. AN IRRIGATED CATHETER WAS USED IN THE EVENT AND THE FLOW SETTING WAS LOW FLOW (2ML/MIN). 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 SET AT 3MM, 3 SEC, 25% OVER 3G, SIZE 3 TAGS WITH RESPIRATORY GATING AND IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584478 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 16 YR Female Life Threatening| R| H SMARTABLATE GENERATOR KIT-US| UNK BAYLIS NRG NEEDLE| UNK_CARTO 3