BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROWGARD BLUE PSI KIT

    MDR report key: 3072696 · Received April 17, 2013

    Report

    Report Number
    MW5029858
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2013, (B)(6) FEMALE ADMITTED TO THE HOSPITAL FOR INVESTIGATION OF CHEST PAIN. PT UNDERWENT A CARDIAC CATHETERIZATION (TRIPLE VESSEL CORONARY ARTERY DISEASE); SCHEDULED FOR CORONARY ARTERY BYPASS SURGERY. PRIOR TO SURGERY, IT WAS IDENTIFIED THAT SHE HAD SEVERE BILATERAL CAROTID DISEASE. CAROTID ENDARECTOMY PERFORMED ON (B)(6) 2013. (B)(6) 2013: PT UNDERWENT CORONARY BYPASS SURGERY TIMES THREE (LIMA-LAD, SVG-OM1, SVG-RCA-). PT TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO CTICU IN STABLE CONDITION AT 1135. IMMEDIATE POST OP UPON ARRIVAL TO CTICU, CHEST X-RAY DONE AS ORDERED. IMPRESSION: A METALLIC LINEAR WIRE WITH A HOOK SEEN PROJECTING FROM THE MEDIAL ASPECT OF THE LEFT CLAVICLE ALONG THE RIGHT HEART BORDER. FURTHER CLINICAL CORRELATION IS RECOMMENDED TO EXCLUDE A FOREIGN BODY. REPEAT CHEST-RAY OCCURS WITH INITIAL STUDY. PT SCHEDULED FOR FOREIGN BODY TRANSCATH RETRIEVAL BY INTERVENTIONAL RADIOLOGY. THE FOREIGN BODY WAS REMOVED WITHOUT ANY COMPLICATIONS. PT DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165633 ARROWGARD BLUE PSI KIT CENTRAL LINE KIT DYB ARROW INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention