BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 21297465 · Received February 3, 2025

    Report

    Report Number
    2029046-2025-00342
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 4, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: THE CODE OF MINOR INJURY (F11) HAS BEEN REMOVED FROM H 6. HEALTH EFFECT - IMPACT CODE AS THIS CODE DOES NOT APPLY TO THE REPORTED EVENT. 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

    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 31437245L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION AND DURING MAPPING, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AT THE TIME OF TACHYCARDIA OCCURRENCE, WHEN MAPPING WAS ATTEMPTED TO BE PERFORMED, BLOOD PRESSURE DECREASED. WHEN CARDIAC SHADOW WAS CHECKED, IT WAS NOT MOVING. THEN, CARDIAC TAMPONADE WAS CONFIRMED. THIS OCCURRED IMMEDIATELY AFTER MAPPING THE LEFT ATRIUM. PERICARDIAL DRAINAGE WAS PERFORMED, AND THE PROCEDURE WAS TERMINATED IN THE MIDDLE OF THE COURSE. AN AMOUNT OF 1,500CC OF ARTERIAL BLOOD WAS DRAINED AND WAS STOPPED SUBSEQUENTLY. BLOOD PRESSURE STABILIZED. THE PATIENT RETURNED TO THE INTENSIVE CARE UNIT (ICU). ABLATION WAS NOT CONDUCTED. THE BLOOD WAS ARTERIAL BLOOD. INSTANTANEOUSLY AFTER TACHYCARDIA OCCURRED, BLOOD PRESSURED DECREASED. THEREFORE, THE PHYSICIAN CONSIDERED A POSSIBILITY THAT THE LEFT ATRIAL APPENDAGE WAS DAMAGED BUT WAS NOT CONFIRMED. PATIENT IMPROVED AFTER AN EXTENDED HOSPITALIZATION. IN THIS PROCEDURE, NONE OF THE BIOSENSE WEBSTER INC. (BWI) ABLATION CATHETERS WERE USED. NO ERROR MESSAGE WAS OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS AROUND 300. IT WAS REPORTED THAT TRANSSEPTAL PUNCTURE WAS PERFORMED AND IT WAS DIFFICULT TO POSITION THE PUNCTURE. OTHER MEDICAL HISTORY REPORTED WAS "AFTER LAPAROSCOPIC SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208436 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31437245L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| H| R FUKUDA DENSHI TRANSSEPTAL NEEDLE.