BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW 22G RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 2809414 · Received October 24, 2012

    Report

    Report Number
    MW5027380
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED ON (B)(6) 2012, DURING SURGERY: ANESTHESIA ATTEMPTED TO PLACE A L BRACHIAL A-LINE FOR MONITORING DURING A CASE. ON CANNULATION OF THE ARTERY, THE METAL GUIDE WIRE SUPPLIED WITH THE ARROW CATHETER SET SPLAYED AND THE INDIVIDUAL FILAMENTS OF THE WIRE UNRAVELED. ONE OF THESE FRAGMENTS BENT INTO A FISHHOOK SHAPE AND BECAME STUCK IN THE ARTERY AND SUBCUTANEOUS TISSUES IN THE ARM. ON ATTEMPT AT RETRIEVAL, THE THIN FILAMENT BROKE. INTRA-OP U/S SHOWED THE FRAGMENT WAS IN THE SUB-Q, NOT WITHIN THE ARTERY, BUT THE FRAGMENT WAS NOT IMMEDIATELY RETRIEVABLE. DATE OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW 22G RADIAL ARTERY CATHETERIZATION SET ART LINE DQY ARROW INTERNATIONAL CF9082449
    2 ARROW 22G RADIAL ARTERY CATHETERIZATION SET ART LINE DQY ARROW INTERNATIONAL CF2080197

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention