BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1102763 · Received August 8, 2008

    Report

    Report Number
    2242445-2008-00029
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A 60 YEAR OLD MALE PATIENT IN A NATIVE SUPERFICIAL VEIN. THE PHYSICIAN MADE ONE PASS AND CAME BACK PROXIMAL WITH THE OVER-THE-WIRE (OTW) PERCUTANEOUS THROMBOLYTIC DEVICE (PTD). AT WHICH TIME, HE NOTICED THAT THE ORANGE PIECE IN THE MIDDLE OF THE OTW PTD CAME OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE THE PIECE FROM THE PATIENT WITHOUT INCIDENT BY USING THE .025 GUIDEWIRE. AS A RESULT, AN "ANGIO JET" WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA PTD PRODUCTS DXE ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention "ANGIO JET" (BRAND UNKNOWN)