BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE INTRODUCER SHEATH

    MDR report key: 38379 · Received August 16, 1996

    Report

    Report Number
    1219544-1996-00022
    Event Type
    Injury
    Date Received
    August 16, 1996
    Date of Event
    July 29, 1996
    Report Date
    August 5, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SHEATH WAS PLACED IN THE RIGHT FEMORAL VEIN FOR A CARDIAC CATHETERIZATION PROCEDURE. A CATHETER WAS PLACED THROUGH THE SHEATH AND REPOSITIONING REQUIRED PULLING THE CATHETER BACK THROUGH THE SHEATH. DURING MANIPULATION THE SHEATH SHEARED AND A PORTION OF THE SHEATH REMAINED IN THE FEMORAL VEIN. THE DETACHED SEGMENT OF SHEATH LODGED IN THE LEFT PULMONARY ARTERY AND WAS RETRIEVED UNDER FLUOROSCOPY IN THE SPECIAL PROCEDURES DEPT. THE PT WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE INTRODUCER SHEATH INTRODUCER SHEATH DYB TERUMO MEDICAL CORP. NA 8895I13

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R