BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE R/O II AND ACCESSORIES

    MDR report key: 8077255 · Received November 16, 2018

    Report

    Report Number
    1118880-2018-00170
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 16, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701007533
    PMA / PMN Number
    K003424
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION AND THE COMPLETED INVESTIGATION. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PHYSICIAN REQUESTED A IK 10CM ROII SHEATH HOWEVER A 6CM ROII SHEATH WAS OPENED AND INADVERTENTLY UTILIZED. DUE TO THE SHORTER SHEATH LENGTH THE SHEATH CAME OUT OF THE ARTERY AND A SURGICAL CUT-DOWN WAS REQUIRED TO CLOSE THE VESSEL. THE PHYSICIAN STATED THAT THE PACKAGING CONTAINS SMALL WRITING MAKING IT DIFFICULT FOR THE STAFF TO SEE WHAT PRODUCT THEY ARE OPENING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 20, 2018. THE BLOOD LOSS WAS REPORTED TO BE UNKNOWN, HOWEVER, A BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920056 PINNACLE R/O II AND ACCESSORIES INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A VH2613 00389701007533

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention