BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12329692 · Received August 17, 2021

    Report

    Report Number
    2029046-2021-01354
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30571227L NUMBER, AND NO INTERNAL ACTION 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 · 1

    IT WAS REPORTED THAT A MALE PATIENT ((B)(6)) BORN ON (B)(6) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND SUFFERED A HEART BLOCK AND A CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. POST PULMONARY VEIN ISOLATION (PVI) PLUS LINES, IMMEDIATELY FOLLOWING MITRAL ISTHMUS (MI) LINE ABLATION, THE ANESTHETIST COMMENTED THAT THERE WAS A DROP IN BLOOD PRESSURE. THE PATIENT ALSO EXPERIENCED AN AV BLOCK. SMALL EFFUSION WAS NOTED, AFTER A PERIOD OF TIME, A PERICARDIAL DRAIN WAS INSERTED. THE PATIENT STABILIZED AND RHYTHM/BLOOD PRESSURE RECOVERED. THERE WAS NO REPORT OF THE PATIENT REQUIRING EXTENDED HOSPITALIZATION. THE PATIENT WAS MOVED TO THE INTENSIVE TREATMENT UNIT (ITU) FOR THE EVENING. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE EVENT WAS NOTICED TOWARDS THE FINAL MINUTES OF THE PROCEDURE, POST ABLATION. THIS ADVERSE EVENT WAS DISCOVERED DURING THE USE OF BIOSENSE WEBSTER INC. (BWI) PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS LIKELY DUE TO THE PERFORATION WITH THE STSF CATHETER DURING ABLATION OR CATHETER MANIPULATION NEAR THE BASE OF THE LEFT ATRIAL APPENDAGE, CAUSING AN EFFUSION. THERE WAS NO BWI PRODUCT MALFUNCTION NOTED. FORCE VISUALIZATION FEATURES USED WERE: GRAPH, DASHBOARD, VECTOR & VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY: 3,3,3, WITH AI (AI 380-500), 3, 3, 25 G, 3 SEC, SIZE 3. TAG INDEX WAS USED AS THE COLOR OPTION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK (ABBOTT) NEEDLE. PRIOR TO NOTING THE CT, AN ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. IRRIGATED CATHETER WAS USED IN THE EVENT AND THE FLOW SETTINGS WERE SET AT STANDARD SETTINGS 8/15MLS (IN THIS CASE 15MLS DUE TO POWER OF 50W). THERE WERE NO ERROR MESSAGES OBSERVED ON THE BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230867 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30571227L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R BRK (ABBOTT) TRANSSEPTAL NEEDLE| UNK_CARTO 3