BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F PEDI CATH LAB INTRODUCER

    MDR report key: 2080089 · Received April 6, 2011

    Report

    Report Number
    1625425-2011-00039
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ARGON MEDICAL DEVICE, INC.
    Product Code
    DRE
    PMA / PMN Number
    K780126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PEDIATRIC HEART CATHETER IN FEMORAL VESSEL. WENT TO PULL SHEATH AND DILATOR. A PIECE OF DILATOR MISSING. SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7F PEDI CATH LAB INTRODUCER DRE ARGON MEDICAL DEVICE, INC. NA 99552210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention