BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 13201307 · Received January 9, 2022

    Report

    Report Number
    2029046-2022-00043
    Event Type
    Injury
    Date Received
    January 9, 2022
    Date of Event
    December 14, 2021
    Report Date
    February 11, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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

    INITIAL REPORTER PHONE: (B)(6). 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2022. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT MAY BE DUE TO THE COMPETITOR'S CATHETER (BEEAT). THE PATIENT WAS REPORTED AS FULLY RECOVERED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. GENERATOR INFORMATION: SMARTABLATE. THEREFORE, UPDATED D 10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES FIELD. INITIALLY THE PRODUCT REPORTED WAS AN UNKNOWN THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. ADDITIONAL INFORMATION PROVIDED THE DEVICE INFORMATION. THEREFORE, UPDATED THE PRODUCT INFORMATION UNDER SECTION D. SUSPECT MEDICAL DEVICE. THE INVESTIGATION WAS COMPLETED ON 03-FEB-2022. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30593300L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN UNKNOWN THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED A PNEUMOTHORAX REQUIRING INTERVENTION. INITIALLY WHEN CARTO 3 WAS BOOTED, ERROR 1 CONTINUES, AND IT TAKES TIME TO GO FROM ERROR 2 TO 3. THE TIME OF ERROR 2 IS ALSO LONGER THAN USUAL. ERROR 911·503, ERROR 258·268·278, AND UNSTABLE COMMUNICATION OCCURRED EVEN AFTER NORMAL ACTIVATION BEYOND ERROR 3 (NORMAL VALUE FOR ALL 6 PATCHES IN THE METAL VALUE). AFTER THE PATIENT INTERFACE UNIT (PIU) SHUTDOWN, THE LOCATION PAD EXTENSION CABLE WAS REPLACED WITH A BACKUP, BUT THIS EVENT WAS FOLLOWED BY UNSTABLE COMMUNICATION. PIU WAS SHUT DOWN AGAIN TO REMOVE THE TWIST OF THE EXTENSION CABLE, AND THE ROOT OF THE PIU AND THE EXTENSION PART WERE RECONNECTED, BUT THE PROBLEM DID NOT RESOLVE. OVER TIME, THE TIME TAKEN TO REACH ERROR 1 BECOMES LONGER AND IT TAKES MORE THAN 5 MINUTES TO REACH ERROR 2, SO THE OPTICAL CABLE WAS CHANGED UNDER SUSPICION. AFTER THAT, COMMUNICATION BECOMES STABLE AND INITIALIZES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS EVENT WAS INITIALLY ASSESSED AS NOT MDR FOR A PIU COMMUNICATION ISSUE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. AT THE END OF THE PROCEDURE, THE PATIENT HAD DIFFICULTY IN BREATHING AND HAD BODY MOVEMENT. PNEUMOTHORAX WAS SUSPECTED ON X-RAY. COMMENT OF THE ATTENDING PHYSICIAN: (B)(6) (BEAT) INSERTION WAS INFLUENCING. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. DRAINAGE WAS PERFORMED BY THE EMERGENCY DOCTOR, AND THE PROCEDURE WAS COMPLETED. ALTHOUGH BLOOD PRESSURE SLIGHTLY DECREASED IN THE EVENING OF THAT DAY, THE PATIENT WAS STABILIZED IMMEDIATELY AFTER THAT, AND THE PATIENT WAS ALREADY DISCHARGED FROM THE HOSPITAL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND IT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. THE ADDITIONAL INFORMATION PROVIDED ON THE MDR REPORTABLE ADVERSE EVENT WAS REPORTED ON (B)(6) 2021. THEREFORE, THE AWARENESS DATE FOR THE ADVERSE EVENT IS (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169976 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30593300L

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention CARTO 3 SYSTEM WITH CARTO MERGE| NON BWI-BEEAT CATHETER| UNKNOWN BRAND OPTICAL CABLE| UNKNOWN BRAND OPTICAL CABLE| UNK_SMARTABLATE GENERATOR