BEUDAMED
    FDA Adverse Event Other Summary report: N

    6F ZUMA

    MDR report key: 210229 · Received February 8, 1999

    Report

    Report Number
    1220452-1999-00002
    Event Type
    Other
    Date Received
    February 8, 1999
    Date of Event
    January 18, 1999
    Report Date
    February 3, 1999
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY PROCEDURE, THE GUIDE WAS OBSERVED TO BE SPLIT 5MM FROM THE TIP. IT WAS NOT SPLIT DURING THE INITAL INSERT. THE SPLIT SECTION DID NOT SEPARATE FROM THE GUIDE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ZUMA FR3.5 DYB MEDTRONIC INTERVENTIONAL VASCULAR, INC. ZM6FR3.5 70897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN