BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY

    MDR report key: 18052155 · Received November 1, 2023

    Report

    Report Number
    2029046-2023-02504
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002416
    PMA / PMN Number
    K090898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31099798M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTION TO THE INITIAL MDR, INCOMPLETE UDI WAS PROVIDED. SECTION D4. PRIMARY UDI NUMBER HAS BEEN UPDATED WITH FULL UDI (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE USING WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT RESULTED IN PROCEDURE CANCELLATION. DURING THE PROCEDURE, THE MEDICAL TEAM NOTED A PERICARDIAL EFFUSION DURING A STANDARD CHECK. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION INCLUDED PROVIDING PROTAMINE TO THE PATIENT AND THE PATIENT CONTINUED TO BE MONITORED. THE PROCEDURE WAS CANCELED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE CAUSE OF THE PERICARDIAL EFFUSION COULD NOT BE CONFIRMED BUT THEY WERE HAVING TROUBLE INSERTING THE CS CATHETER EARLIER IN THE PROCEDURE. THE CATHETER HAD AN ISSUE FALLING OUT AND ¿KEEPING IT IN¿. THE PHYSICIAN COULD NOT CONFIRM IF THIS CAUSED THE PERICARDIAL EFFUSION OR IF IT WAS CAUSED BY SOMETHING ELSE PRIOR TO THE PROCEDURE. PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. THE PATIENT HAD FULLY RECOVERED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED PRIOR TO NOTING PERICARDIAL EFFUSION. NO EVIDENCE OF STEAM POP. THIS OCCURRED DURING THE MAPPING PHASE. THE FELLOW AND ATTENDING BOTH HAS ISSUES GETTING CS (CORONARY SINUS) CATHETER IN PLACE. WHEN THE CATHETER WAS BELIEVED TO BE SECURED, IT'D WORKED ITS WAY OUT OF PLACE SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157283 WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC 31099798M 10846835002416

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Life Threatening| R OCTARAY CATHETER| SMARTABLATE GENERATOR| SOUNDSTAR CATHETER