BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 18759131 · Received February 22, 2024

    Report

    Report Number
    2029046-2024-00589
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 30, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009972
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT SUFFERED CARDIAC PERFORATION AND PERICARDIAL EFFUSION. NO ABLATIONS HAD BEEN PERFORMED. AFTER FAST ANATOMICAL MAPPING (FAM) WITH THE ABLATION CATHETER IN THE RIGHT ATRIUM AND AFTER TRANSSEPTAL ACCESS, THE EFFUSION WAS NOTICED WHILE PLACING THE WEBSTER CS CATHETER. THE MEDICAL TEAM WAS UNSURE WHEN THE PERFORATION OCCURRED/EFFUSION DEVELOPED, BUT THE PHYSICIAN INDICATED IT MAY HAVE BEEN WHEN THE BAYLIS VERSA CROSS TRANSSEPTAL WIRE WAS IN THE RIGHT ATRIUM. THE EFFUSION COULD HAVE BEEN PRESENT BEFORE THIS. THERE WAS A SUBSTANTIAL AMOUNT OF FLUID NOTICED IN THE PERICARDIUM WITH THE INTRACARDIAC ECHO CATHETER. THE PATIENT'S BLOOD PRESSURE DECREASED TO 55 SYSTOLIC. A PERICARDIOCENTESIS WAS PERFORMED REMOVING ONE LITER OF FLUID. THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE ICU FOR RECOVERY AND OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61748 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 10846835009972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R BAYLIS VERSACROSS TRANSSEPTAL WIRE