BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10666545 · Received October 12, 2020

    Report

    Report Number
    2029046-2020-01469
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 · 1

    (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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE. AT THE BEGINNING OF AFIB ABLATION PROCEDURE, THE PHYSICIAN WANTED TO START FAST ANATOMICAL MAPPING (FAM) VIEW BUT WHEN ZOOMED IN, THE FAM DISAPPEARED. VISUALIZATION MATRIX IS NOT BUILT, ABLATION CATHETER DISAPPEARED IN THE BACKGROUND, WENT BLACK. THE PHYSICIAN ZOOMED IN AND COULDN'T SEE ANYTHING. WHEN THE PHYSICIAN ZOOMED OUT, THEY REGAINED VISION AGAIN. THE PHYSICIAN PERFORMED A CAVOTRICUSPID ISTHMUS (CTI) ABLATION IN THE RIGHT ATRIUM AT 50 WATTS WITH THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. AFTER 30 SECONDS OF ABLATING, A STEAM POP OCCURRED. AT THE END OF THE PROCEDURE, THE PATIENT WENT TO RECOVERY ROOM IN APPARENTLY NORMAL CONDITION. HOWEVER, WHEN THE PHYSICIAN CAME BACK TO CHECK ON THE PATIENT 50 MINUTES LATER, HE HAD NOTICED A TAMPONADE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE VISUALIZATION ISSUE IS NOT MDR-REPORTABLE. THE STEAM POP IS NOT AN MDR-REPORTABLE ISSUE. CARDIAC TAMPONADE MAY BE LIFE THREATENING; MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130339 THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-WW| SMARTABLATE PUMP KIT-WW