BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 20355867 · Received October 2, 2024

    Report

    Report Number
    2029046-2024-03269
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 6, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021141
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, IT WAS REPORTED THAT THE SHEATH WAS A SWARTZ SL0 MADE BY ABBOTT. THEREFORE, THE CONCOMITANT PRODUCT SECTION WAS UPDATED. 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 CARDIAC ABLATION PROCEDURE, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIAL DRAIN PLACEMENT AND BLOOD TRANSFUSION. DURING THE CASE, AFTER TRANSEPTAL AND DURING THE MAPPING PHASE (BEFORE ANY ABLATION), THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PHYSICIAN CHECKED THE INTRACARDIAC ECHO AND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIAL DRAIN WAS USED, BLOOD WAS GIVEN, AND THE CASE WAS ABANDONED. AN OCTARAY CATHETER (D160901) AND A QDOT MICRO D/F CATHETER (D139505) WERE IN THE LEFT ATRIUM ACROSS THE TRANSEPTAL AT THE TIME OF EFFUSION. NO ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. THE EFFUSION WAS NOTICED AT THE MAPPING STAGE. ONLY THE OCTARAY WAS USED FOR MAPPING. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE (TRANSSEPTAL). TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK NEEDLE AND THE PHYSICIAN NOTED THAT THE NEEDLE DID NOT NEED TO BE DEPLOYED, AS THE SHEATH WENT ACROSS WITHOUT THE NEEDLE. THERE WAS NO ERROR MESSAGE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE INTERVENTION INCLUDED A PERICARDIAL DRAIN BEING INSERTED; HEPARIN WAS REVERSED WITH PROTAMINE TO MINIMIZE BLEEDING. APPROXIMATELY 800ML OF BLOOD WAS DRAINED FROM THE PERICARDIAL SPACE AND A UNIT OF O- BLOOD WAS GIVEN. THE PATIENT FULLY RECOVERED; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED TO MONITOR THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017356 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 10846835021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R BRK NEEDLE (ABBOTT).| NGEN GENERATOR| QDOT MICRO, BI, TC, D-F| SWARTZ SL0 SHEATH (ABBOTT).