BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000102-1999-00007

    MDR report key: 258075 · Received December 17, 1999

    Report

    Report Number
    6000102-1999-00007
    Event Type
    Injury
    Date Received
    December 17, 1999
    Date of Event
    November 16, 1999
    Report Date
    December 17, 1999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHILE ATTEMPTING TO CATHETERIZE AN ANEURYSM. WHILE ADVANCING DOWN OVER THE ARCH OF THE AORTA, THE GUIDE CATHETER DOUBLED OVER ON ITSELF. THE ENTIRE SYSTEM WAS REMOVED. PT STATUS IS LISTED AS "OKAY".

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention