BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 15422276 · Received September 14, 2022

    Report

    Report Number
    2029046-2022-02218
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 23, 2022
    Report Date
    October 17, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 4. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 21-SEP-2022 STATING THAT THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION HAS BEEN COMPLETED ON 17-OCT-2022. 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 30842451L 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT SUFFERED A CARDIAC ARREST. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT CODED. AFTER GOING TRANSSEPTAL AND WHEN MAPPING IN THE LEFT ATRIUM, THE PHYSICIAN HAD NOTICED THAT THE PATIENT HAD NO HEART BEAT OR PULSE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED ON THE PATIENT. THEN A STRONG PULSE WAS RESTORED IN THE PATIENT, CONTRAST DYE WAS INJECTED INTO THE PATIENT AND IT WAS CONFIRMED VIA CONTRAST DYE THAT THE PATIENT'S ARTERIES WERE "CLEAN," AND THERE WAS NO EFFUSION PRESENT. THE PATIENT CONTINUED TO BE MONITORED, AND THE CALLER REPORTED THAT PATIENT IS IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE PATIENT WENT INTO PEA (PULSELESS ELECTRICAL ACTIVITY). NO ABLATION HAD BEEN PERFORMED DURING THE PROCEDURE AND THEY HAD ONLY BEEN MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS UNDETERMINED. PATIENT WAS STABLE WHEN THEY WERE ROLLED OUT OF THE ROOM. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE WAS NOT SURE OF THEIR CONDITION PAST THAT. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU). ABLATION WAS NOT PERFORMED PREVIOUS TO THE EVENT; THEREFORE, NO ABLATION CATHETER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2674348 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30842451L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R