BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11716827 · Received April 23, 2021

    Report

    Report Number
    2029046-2021-00656
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 30475719M 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 A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER ON (B)(6) 2021 AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, ANTICOAGULATION THERAPY AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). DURING THE PROCEDURE, WHILE ABLATING THE LEFT VENTRICLE (LV), THE PATIENT BECAME HYPOTENSIVE AND CARDIAC TAMPONADE OCCURRED. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN 800CC OF FLUID FROM THE PERICARDIAL SPACE. SURGICAL INTERVENTION WAS NOT REQUIRED; HOWEVER, THE PATIENT UNDERWENT ANTICOAGULATION THERAPY AND PCPS. PROLONGED HOSPITALIZATION WAS REQUIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021 FULLY RECOVERED. THE PHYSICIAN COMMENTED THAT THE CAUSE OF CARDIAC TAMPONADE WAS UNKNOWN AND IT WAS NOT RELATED TO THE BIOSENSE WEBSTER, INC. CATHETER. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION NOR ANY OTHER PRODUCT DEFICIENCY. SINCE THE EVENT (CARDIAC TAMPONADE) IS LIFE THREATENING AND REQUIRED INTERVENTION AND PROLONGED HOSPITALIZATION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION, OR PERMANENT DAMAGE OF A BODY STRUCTURE, THEN IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610689 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30475719M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R