BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2018687 · Received March 9, 2011

    Report

    Report Number
    MW5019761
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    November 23, 2010
    Report Date
    March 9, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, OUTPATIENT CAME IN TO RADIOLOGY FOR PICC -PERIPHERALLY INSERTED CATHETER-PLACEMENT. IT WAS INSERTED AT 14:20 IN RIGHT BRACHIAL VEIN WITH NO COMPLICATIONS. RADIOGRAPHIC PLACEMENT CONFIRMED. DURING TRANSPORT BACK HOME, PT COMPLAINED OF CHEST PAIN, RELIEVED WITH NITROGLYCERIN. PT RETURNED TO HOSP AND ADMITTED TO ICU FOR EVAL AND MEDICAL MGMT. ON (B)(6) 2010, CT CHEST SHOWED CAVITY IN LEFT UPPER LOBE. FURTHER REVIEW OF CT SCAN SHOWED POSSIBLE LEAD IN RIGHT VENTRICLE EXTENDING INTO INFERIOR VENA CAVA. ECHOCARDIOGRAM DONE SHOWED LINEAR STRUCTURE IN RIGHT VENTRICLE EMBEDDED IN RIGHT VENTRICULAR WALL. ON (B)(6) 2010, GUIDEWIRE EXTRACTION PERFORMED IN THE CATH LAB. THE GUIDE WIRE USED TO PLACE PICC LINE HAD SEPARATED DURING PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR BMW .014 INTERVENTIONAL WIRE DQX ABBOTT VASCULAR 1009660J

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability