BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8061948 · Received November 12, 2018

    Report

    Report Number
    2029046-2018-02260
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    October 16, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# UNKNOWN, SERIAL# UNKNOWN), NON-BWI REPROCESSED SOUNDSTAR ECO (MODEL# R10439072, LOT# 2071611), ST.JUDE AGILIS MEDIUM CURVE SHEATH (MODEL# UNKNOWN, LOT# UNKNOWN) . MANUFACTURER REF NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE CASE, CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). THERE WERE NO VISIBLE SIGNS OF THIS CONDITION ON THE PATIENT. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO BE IN STABLE CONDITION. EXTENDED HOSPITALIZATION WAS REQUIRED. THE PATIENT STAYED A FEW EXTRA DAYS AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME WAS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION AND ANATOMY, ALSO POSSIBLY RELATED TO HIGH FORCE APPLIED DURING THE PROCEDURE. AN ANEURYSM IN THE LEFT VENTRICLE (LV) WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. AN AGILIS MEDIUM CURVE SHEATH WAS USED DURING THE PROCEDURE. THE GENERATOR WAS USED IN POWER CONTROL MODE AT 35 WATTS. THE POWER WAS NOT TITRATED DURING THE ABLATION. THE CATHETER IRRIGATION WAS SET AT 15CC/MIN. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) OF 350 SECONDS. THE STSF CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER AND IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898509 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30058232L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R