BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12776564 · Received November 9, 2021

    Report

    Report Number
    2029046-2021-01913
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 30616713L 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 FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. AT THE END OF A PULMONARY VEIN ISOLATION, THE BLOOD PRESSURE OF THE PATIENT WAS LOW. THE ULTRASOUND CHECK SHOWED NOTHING CONCLUSIVE. AFTER SOME TIME (~1H AFTER THE END OF THE PROCEDURE), THE BLOOD PRESSURE ISSUE WAS STILL PRESENT AND IT APPEARED TO BE A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED. THE TRANSEPTAL PUNCTURE WAS DIFFICULT (IT WAS DONE WITH TRANS ESOPHAGEAL ECHO. DURING THE RADIO FREQUENCY APPLICATION, 30W / 300 AI TARGET WAS USED FOR THE RIGHT POSTERIOR WALL AND 40W / 350-400 AI TARGET WAS USED FOR THE ANTERIOR PARTS. NO ABLATION WAS MADE ON THE LEFT POSTERIOR WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE AND PATIENT CONDITION RELATED. THE CAUSE IS UNKNOWN FOR THE PHYSICIAN, SINCE THE EVENT WAS NOTED AT THE END OF THE PROCEDURE. THE TRANSSEPTAL PUNCTURE WAS DIFFICULT AND NO RELEVANT EVENT (STEAM POP, HIGH FORCE, ETC) WAS OBSERVED DURING THE PROCEDURE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE PATIENT PREVIOUSLY HAD A CTI INTERVENTION WITH A DIFFICULT ACCESS. GENERATOR USED WAS THE SMARTABLATE. FORCE VISUALIZATION FEATURES USED: GRAPH, DASHBOARD, VECTOR & VISITAG WITH VISITAG MODULE PARAMETERS FOR STABILITY: 25% 3G, 3S. RESPIRATION ADJUSTMENT WAS AN ADDITIONAL FILTER USED WITH THE VISITAG. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN NEEDLE. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. NO EVIDENCE OF STEAM POP. THE EVENT WAS NOTED AT THE END OF THE PROCEDURE (AFTER TSP, MAPPING AND ABLATION). IRRIGATED CATHETER WAS USED IN THE EVENT, AND THE FLOW SETTING: STANDARD SETTING, 2/8/15. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678302 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30616713L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R| H 71CM TRANSSEPTAL NEEDLE| PENTARAY NAV ECO 7FR, F, 2-6-2| UNKNOWN BRAND PUMP| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR