BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 16773433 · Received April 19, 2023

    Report

    Report Number
    2029046-2023-00856
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 22, 2023
    Report Date
    April 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008791
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 NUMBER LOT 30963886M 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE (CT) REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THEY WERE IN A LIVE PROCEDURE AND THE CARTO 3 SYSTEM DISPLAYED A MESSAGE THAT IT NEEDED TO RESTART AND RESTARTED ON ITS OWN. DURING THE INITIAL INTAKE OF INFORMATION, THEY STATED THAT THEY WERE ABLE TO OPEN THE SAME STUDY AND CONTINUED THE PROCEDURE. IT WAS ALSO REPORTED THAT EARLIER IN THE PROCEDURE, THEY HAD A PATIENT COMPLICATION. IT WAS REPORTED THAT AFTER THE AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. THEY LOOKED ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND NOTICED A PERICARDIAL EFFUSION (PE) IN THE LEFT VENTRICAL (LV). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THEY STATED AT THE TIME OF THE INJURY, THE ONLY BWI PRODUCTS IN THE BODY WERE A SOUNDSTAR CATHETER (R10439011/LOT# 2185703) AND A DECA NAV CATHETER (R7D282CT/LOT# 30963886M). BOTH CATHETERS ARE NOT AVAILABLE TO RETURN. THE ADVERSE EVENT OCCURRED ON 03-MAR-2023. IT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE AND PATIENT RELATED, UNRELATED TO BWI PRODUCTS. PERICARDIOCENTESIS WAS DONE. OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. AN RF GENERATOR WAS USED, SERIAL NUMBER G4RC-0571, PIU 29048. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE PE OR CT, ABLATION WAS NOT PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING THE MAPPING PHASE. THE SOFTWARE CRASH IS NOT MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685722 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC R7D282CT 30963886M 10846835008791

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L 7FR DECAN,11P,D,2.4MMLE,282MM,| CARTO 3 SYSTEM| REPROCESS SDSTR ECO 8F-90 SMS| UNK RF GENERATOR