BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12264661 · Received August 3, 2021

    Report

    Report Number
    2029046-2021-01252
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). 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 30526981L 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 (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED A STROKE AND WAS TRANSFERRED TO A HOSPITAL FOR STROKE CARE. PULMONARY VEIN ISOLATION (PVI) ABLATION WITH SUCCESSFUL ISOLATION OF PULMONARY VEINS. WHEN THE PATIENT WOKE FROM ANESTHETIC HE HAD LEFT LEG WEAKNESS UNDER THE MOUNT STROKE PROTOCOL THE PATIENT WAS TRANSFERRED TO SCGH. THE PVI ABLATION WITH CATHETERS HAD NO INCIDENTS DURING THE PROCEDURE WITH VEIN ISOLATION WE DID LOSE TRANSEPTAL ACCESS MOMENTARILY THERE WAS NO CONCERNS DURING THE PROCEDURE FROM THE PHYSICIAN. THE TRANSEPTAL PUNCTURE WAS PERFORMED UNDER TOE GUIDANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS EVENT WAS FIRST NOTICED WHEN THE PATIENT RETURNED TO THE WARD. ONCE THE PROCEDURE FINISHED HE WAS AWAKEN IN THE CATH LAB BY THE ANESTHETIST AND THEN FROM THE CATH LAB HE WENT TO THEATRE RECOVERY TILL FULLY RECOVERED AND THEN TO THE WARD. IT WAS ON THE WARD THAT LEFT LEG WEAKNESS WAS FIRST REPORTED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: THE PROCEDURE WENT WELL WITH NO INCIDENT NOTICED IN THE PROCEDURE OR POST PROCEDURE BY THE ANESTHETIST. THE ACT LEVELS DURING THE PROCEDURE WITH HEPARIN POST TRANSEPTAL PUNCTURE WERE WITHIN NORMAL LIMITS. THERE WAS NO COAGULATION SEEN ON THE CATHETER WHEN IT WAS REMOVED AT THE END OF THE PROCEDURE. THE PHYSICIAN DID NOT STATE THAT THIS WAS CAUSED BY THE BW PRODUCT. ONCE NOTIFIED BY THE WARD OF THE LEFT LEG WEAKNESS THE PHYSICIAN SENT THE PATIENT TO SCGH UNDER THE STROKE PROTOCOL AT THE MOUNT HOSPITAL. THE PATIENT OUTCOME OF THE ADVERSE EVENT: DEATH THE PATIENT IS UNDER THE CARE OF THE STROKE TEAM AT SCGH. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT: THE PATIENT WAS TRANSFERRED FROM THE MOUNT HOSPITAL TO SCGH. HE IS UNDER THE STROKE TEAM. SINCE THE EVENT IS LIFE THREATENING AND REQUIRED INTERVENTION AND PROLONGED HOSPITALIZATION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167827 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30526981L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R