BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 15325317 · Received August 30, 2022

    Report

    Report Number
    2029046-2022-02046
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 30, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30812284L NUMBER, AND NO INTERNRAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. THE PATIENT SUFFERED A PERICARDIAL EFFUSION WHILE MAPPING THE LEFT ATRIUM WITH THE PENTARAY CATHETER. THE PATIENT¿S PRESSURE DROPPED. THE INTRACARDIAC ECHO (ICE) CATHETER (REPROCESSED BY INNOVATIVE HEALTH), WAS USED TO CONFIRM A PERICARDIAL EFFUSION. ECHO WAS CALLED AND ALSO CONFIRMED THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND FLUID (AMOUNT UNKNOWN) WAS REMOVED FROM THE PERICARDIAL SPACE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND WAS KEPT OVERNIGHT TO MONITOR VITALS/STATUS. THE PHYSICIAN SUSPECTED A PERFORATION OF THE LEFT ATRIAL APPENDAGE AT TIME OF THE TRANSSEPTAL. THE TRANSSEPTAL NEEDLE USED WAS NOT A BIOSENSE WEBSTER PRODUCT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS UNDETERMINED. THE PHYSICIAN THOUGHT THAT IT WAS A MIX BETWEEN THE PATIENT¿S CONDITION (POSSIBLY FRIABLE TISSUE) AND THE PROCEDURE (TRANSSEPTAL ACCESS). NO ABLATION WAS PERFORMED YET. THEY WERE IN THE MAPPING PHASE WHEN THE EFFUSION WAS NOTED. THE EVENT OCCURRED DURING THE MAPPING PHASE. CONSERVATIVELY, THIS WAS ASSESSED AS MDR REPORTABLE AGAINST THE PENTARAY AS IT WAS IN USE DURING MAPPING WHEN THE CARDIAC TAMPONADE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067569 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30812284L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening INNOVATIVE HEALTH REPROCESSED ICE CATHETER| NON-BWI TRANSSEPTAL NEEDLE| PENTARAY NAV ECO 7FR, D, 2-6-2| TRNSPTL FXD SHEATH,63CM,ML0