BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE INTRODUCER SHEATH 8 FR

    MDR report key: 34989 · Received July 30, 1996

    Report

    Report Number
    1219544-1996-00018
    Event Type
    Injury
    Date Received
    July 30, 1996
    Date of Event
    April 22, 1996
    Report Date
    July 22, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A RENAL ANGIOGRAM WAS PERFORMED WITHOUT INCIDENT AND THE PT WAS TRANSFERRED TO HIS ROOM. BLEEDING WAS NOTED AT THE INSERTION SITE. THE DRESSING WAS LIFTED AND IT WAS NOTED THE INTRODUCER SHEATH WAS CRACKED. THE SHEATH WAS REMOVED AND THE PT'S HEART RATE DECREASED. MEDICATION AND FLUIDS WERE ADMINISTERED AND NO FURTHER PT COMPLICATIONS ENSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE INTRODUCER SHEATH 8 FR SHEATH DYB TERUMO MEDICAL CORP. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention