BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERVENTIONAL PSI SET

    MDR report key: 167413 · Received May 12, 1998

    Report

    Report Number
    1036844-1998-00057
    Event Type
    Injury
    Date Received
    May 12, 1998
    Date of Event
    June 1, 1995
    Report Date
    May 7, 1998
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT THE PT UNDERWENT A CARDIAC CATHETER PROCEDURE ON JUNE 23, 1995 AS AN OUT-PT. THE PROCEDURE WAS UNCOMPLICATED AND UNEVENTFUL. SUBSEQUENTLY, THE PT BEGAN TO DEVELOP VAGUE ABDOMINAL FLANK PAIN. DIAGNOSTIC EVALUATION REVEALED A CATHETER-LIKE STRUCTURE IN THE RIGHT COMMON ILIAC ARTERY. THE PT UNDERWENT SURGERY AND A SMALL BLUE CATHETER WAS REMOVED FROM THE AORTIC PERFORATION. THE PT'S CONDITION WAS CONSIDERED TO BE GOOD AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERVENTIONAL PSI SET CATHETER INTRODUCER SET DYB ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention