BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 11882694 · Received May 26, 2021

    Report

    Report Number
    1721504-2021-00035
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 13, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    PQH
    UDI-DI
    00884450149331
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND 2 SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. CORRECTIVE ACTIONS ARE IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS CORONARY INTERVENTION [PCI], AIR WAS INTRODUCED INTO THE PATIENT VASCULATURE SYSTEM. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ASCENDING AORTA UNDER FLUOROSCOPY WITH A GUIDE CATHETER OVER A GUIDEWIRE, TO SUCCESSFULLY CANNULATE AND OPACIFY A NATIVE CORONARY ARTERY. DURING THE PROCEDURE, AIR WAS INTRODUCED FROM A LEAK IDENTIFIED AT THE CONNECTION BETWEEN THE HPF TUBING AND A CONNECTOR DURING POWER INJECTIONS. THE PATIENT'S BP DRASTICALLY DROPPED, AND THE PATIENT WENT INTO TEMPORARY CARDIOPULMONARY ARREST AND WAS RESUSCITATED BY CPR. A CODE WAS CALLED AND EMERGENT ACLS/BLS MEDICAL INTERVENTION WAS ACTIVATED ACCORDING TO HOSPITAL PROTOCOL. THE PATIENT WAS TRANSFERRED TO ICU AND THE NEXT DAY TRANSFERRED TO A STEPDOWN UNIT FOR RECOVERY. NO ADDITIONAL CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787114 MERIT CUSTOM KIT CUSTOM KIT PQH MERIT MEDICAL SYSTEMS INC. H1650902 00884450149331

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R INJECTOR SYRINGE