BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO PINNACLE R/O II INTRODUCER SHEATH

    MDR report key: 12252466 · Received July 29, 2021

    Report

    Report Number
    MW5102858
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 27, 2021
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TERUMO PINNACLE R/O II INTRODUCER SHEATH WITH RADIOPAQUE MAKER 8 FRENCH 25 CM FRACTURED DURING AN ENDOVASCULAR PROCEDURE RESULTING IN A RETAINED FOREIGN BODY. THE PATIENT REQUIRED EXPLORATORY SURGERY AND REMOVAL OF THE RETAINED FOREIGN BODY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140716 TERUMO PINNACLE R/O II INTRODUCER SHEATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORP. RSB803 0000035077

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization