BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK V PROVIS

    MDR report key: 19051844 · Received April 5, 2024

    Report

    Report Number
    2520313-2024-00007
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BAYER MEDICAL CARE INC
    Product Code
    DXT
    PMA / PMN Number
    K903390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® MARK V PROVIS INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED (B)(6) 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. MULTIPLE ATTEMPTS TO OBTAIN THE DISPOSABLES IN USE DURING THE EVENT WERE UNSUCCESSFUL. LOT NUMBERS FOR THE SUBJECT DISPOSABLES INVOLVED IN THE EVENT WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES IS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® MARK V PROVIS INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE, CONNECTOR TUBING AND CATHETER. AIR EMBOLISM CAN CAUSE PATIENT INJURY OR DEATH. OPERATOR VIGILANCE AND CARE, COUPLED WITH A SET PROCEDURE IS ESSENTIAL TO THE AVOIDANCE OF AIR EMBOLISM. 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® MARK V PROVIS INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED (B)(6) 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. ON (B)(6) 2024 BAYER PRODUCT ANALYSIS RECEIVED AND TESTED THE MEDRAD® MARK V PROVIS STERILE DISPOSABLE SYRINGE (150-FT-Q) AND MEDRAD® HIGH PRESSURE CONNECTOR TUBING (B)(6), LOT NUMBERS UNKNOWN, IN USE DURING THE PROCEDURE AND CONCLUDED THAT THEY PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® MARK V PROVIS INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE, CONNECTOR TUBING AND CATHETER. AIR EMBOLISM CAN CAUSE PATIENT INJURY OR DEATH. OPERATOR VIGILANCE AND CARE, COUPLED WITH A SET PROCEDURE IS ESSENTIAL TO THE AVOIDANCE OF AIR EMBOLISM. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT AN 87-YEAR-OLD FEMALE UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® MARK V PROVIS INJECTION SYSTEM ((B)(6)). THE CUSTOMER REPORTED THAT DURING THE LAST INJECTION OF THE PROCEDURE, AN UNDISCLOSED AMOUNT OF AIR WAS OBSERVED ON THE DISPLAYED IMAGE AND IN THE TUBING FROM THE INJECTOR TO THE PATIENT. AT THE CONCLUSION OF THE PROCEDURE, WHILE THE PATIENT WAS IN THE POST ANESTHESIA CARE UNIT (PACU), A CODE STROKE WAS INITIATED. NEUROLOGY WAS CONSULTED AND SUBSEQUENT RADIOLOGY STUDIES WERE PERFORMED. THE PATIENT HAS SINCE BEEN ADMITTED TO INPATIENT REHABILITATION AND IS REPORTED AS DOING WELL.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT AN 87-YEAR-OLD FEMALE UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® MARK V PROVIS INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT DURING THE LAST INJECTION OF THE PROCEDURE, AN UNDISCLOSED AMOUNT OF AIR WAS OBSERVED ON THE DISPLAYED IMAGE AND IN THE TUBING FROM THE INJECTOR TO THE PATIENT. AT THE CONCLUSION OF THE PROCEDURE, WHILE THE PATIENT WAS IN THE POST ANESTHESIA CARE UNIT (PACU), A CODE STROKE WAS INITIATED. NEUROLOGY WAS CONSULTED AND SUBSEQUENT RADIOLOGY STUDIES WERE PERFORMED. THE PATIENT HAS SINCE BEEN ADMITTED TO INPATIENT REHABILITATION AND IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545168 MARK V PROVIS ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC 59352842

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other HIGH PRESSURE CONNECTOR TUBING| MARK V PROVIS STERILE DISPOSABLE SYRINGE