BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO PINNACLE INTRODUCER

    MDR report key: 529337 · Received January 7, 2004

    Report

    Report Number
    529337
    Event Type
    Injury
    Date Received
    January 7, 2004
    Date of Event
    December 2, 2003
    Report Date
    December 5, 2003
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH ACUTE MYOCARDIAL INFARCTION. PHYSICIAN NOT ABLE TO ADVANCE EP CATHETER INTO VENOUS SYSTEM ANY FURTHER THAN GROIN AREA. SHEATH CAME OUT (SHEARED OFF) WHEN CATH REMOVED. OTHER END IN PT FOREIGN BODY NOTED IN GROIN WITH FLUOROSCOPY. VASCULAR SURGERY CONSULTED AND PT UNDERWENT SURGERY FOR REMOVAL OF SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PINNACLE INTRODUCER SHEATH DYB TERUMO MEDICAL CORP. 15-723 (M001157230) DA06

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention