BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 22412950 · Received July 7, 2025

    Report

    Report Number
    2029046-2025-02195
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 7, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31592779L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 DURING ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE/PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED DURING THE PROCEDURE. THE PATIENT'S BLOOD PRESSURE WAS LOW, BUT UNSURE IF THE PATIENT'S BLOOD PRESSURE HAD DROPPED. MID-CASE, THE PHYSICIAN USED THE SOUNDSTAR ICE CATHETER TO LOOK AT THE VENTRICLE AND A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED. SOME ABLATIONS HAD BEEN PERFORMED USING ONLY THE MEDTRONIC PULSE SELECT SYSTEM. THE PROCEDURE WAS ABORTED. THE MEDICAL INTERVENTION PERFORMED WAS A PERICARDIOCENTESIS. THE LAST KNOWN PATIENT STATUS WAS STABLE. BWI CATHETERS USED DURING THE CASE WERE THE SOUNDSTAR ICE CATHETER AND THE OCTARAY MAPPING CATHETER. THE CARTO 3 SYSTEM WAS USED FOR MAPPING AND THE MEDTRONIC PULSE SELECT SYSTEM WAS USED FOR ABLATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757637 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31592779L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO 3 SYSTEM| MEDTRONIC PULSESELECT SYSTEM| SOUNDSTAR ECO GE 8F CATHETER