BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA CATH SET: 20 GA X 1-3 /4

    MDR report key: 1003885 · Received February 15, 2008

    Report

    Report Number
    9680794-2008-00001
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    k810675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT WAS REC'D BY MEDWATCH. IT WAS REPORTED THAT A RIGHT TOTAL KNEE ARTHROPLASTY WAS BEING PERFORMED ON THE PT. "20G ARROWCATH 0.46 SPRING WIRE GUIDE BROKE OFF INSIDE PT'S RIGHT RADIAL ARTERY LEAVING 4MM OF WIRE INSIDE PT. (THESE WIRES ARE NORMALLY VERY STRONG AND I WAS UNABLE TO BREAK ANOTHER WHEN TRYING TO TEST THEIR STRENGTH). THE WIRE THAT BROKE WAS BARELY STRESSED + UNRAVELED WITH VERY GENTLE TRACTION AS I ATTEMPTED TO REMOVE IT." - PHYSICIAN'S IMPRESSION. ON 2/4/08 F/U INFO STATED THE PIECE WAS SURGICALLY REMOVED FROM THE PT. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA CATH SET: 20 GA X 1-3 /4 RADIAL ARTERY PRODUCTS DQO ARROW INTERNATIONAL INC * CF7049014

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention