BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 18148625 · Received November 16, 2023

    Report

    Report Number
    2520313-2023-00030
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    November 7, 2023
    Report Date
    September 25, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258021447
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS COMPLETED ON (B)(6) 2023 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. A REQUEST FOR ADDITIONAL PROCEDURE RELATED INFORMATION, INCLUDING AVAILABILITY OF THE ASSOCIATED DISPOSABLES FOR EVALUATION, HAS BEEN MADE TO THE CUSTOMER AND WE ARE AWAITING THEIR RESPONSE. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS COMPLETED ON NOVEMBER 9, 2023 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MULTI-PATIENT STERILE DISPOSABLE SET (MPAT, LOT NUMBER 224302), AVANTA SYRINGE (LOT NUMBER 8420412) AND THE SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT, LOT NUMBER 230604) THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE CUSTOMER. FUNCTIONAL TESTING OF A RETAINED AVANTA SYRINGE, MPAT, AND SPAT FROM THE RELEVANT LOTS CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE CUSTOMER DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTION: FOR UDI DATA DISCREPANCY/MISMATCH ON PREVIOUSLY SUBMITTED MDR AND TO ENSURE THE DEVICE IDENTIFICATION DATA IS IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    ON NOVEMBER 9, 2023 BAYER SERVICE RECEIVED INFORMATION THAT A PATIENT SUFFERED AN INTRAPROCEDURAL INFARCTION DUE TO AN ALLEGED AIR EMBOLISM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6). THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    ON NOVEMBER 9, 2023, BAYER SERVICE RECEIVED INFORMATION THAT A PATIENT SUFFERED AN INTRAPROCEDURAL INFARCTION DUE TO AN ALLEGED AIR EMBOLISM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6). ON NOVEMBER 27, 2023, BAYER MEDICAL CARE INC. RECEIVED THE FOLLOWING PROCEDURE-RELATED INFORMATION: A 78-YEAR OLD MALE PATIENT WAS UNDERGOING CORONARY ANGIOGRAPHY WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT THERE WAS A CORONARY ARTERY OCCLUSION DURING THE FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT WHICH CAUSED AN ST ELEVATION ON THE ECG TRACING. THE ATTENDING PHYSICIAN STATED THAT THEY COULD NOT BE SURE THAT IT WAS AN AIR EMBOLIZATION BUT COULD NOT EXCLUDE THIS AS THE CAUSE OF THE OCCLUSION. DURING THE INDEX PROCEDURE OF THE FFR MEASUREMENT, THE DISTAL LAD (LEFT ANTERIOR DESCENDING ARTERY) WAS TREATED WITH BALLOON DILATATION AND ECHOCARDIOGRAPHY AFTER WHICH THE PATIENT WAS REPORTED TO HAVE A TOTAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161775 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 86600153 00616258021447

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other MULTI-PATIENT DISPOSABE SET (MPAT).| MULTI-PATIENT DISPOSABLE SET (MPAT).| SINGLE-PATIENT DISPOABLE SET (SPAT).| SINGLE-PATIENT DISPOSABLE SET (SPAT).