BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURNPIKE LP

    MDR report key: 7430410 · Received April 13, 2018

    Report

    Report Number
    2134812-2018-00020
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 15, 2018
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQY
    UDI-DI
    M20656390
    PMA / PMN Number
    K151981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS COMPLETED AND ZERO NONCONFORMANCES WERE FOUND. THE RETURNED PRODUCT EVALUATION CONFIRMED THE DAMAGE TO THE TURNPIKE TIP. THE DISTAL TIP WAS SEPARATED AND THERE WAS ABOUT 4 MM MISSING. THE DAMAGE FOUND IS CONSISTENT WITH OVER TORQUING THE DEVICE AGAINST RESISTANCE.

    Description of Event or Problem · 1

    THE TIP OF THE TURNPIKE LP DID BREAK LOOSE IN THE LAO. DR. DID CAPTURE THE TIP OF THE TURNPIKE WITH THE WIRE. REPORTED THE LOA HAD ATHEROSCLEROSIS IN THE LOA ARTERY WITH (CAC) CORONARY ARTERY CALCIFICATION. REPORTED THAT THERE WAS NO PATIENT INJURY OR CONSEQUENCE, PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273598 TURNPIKE LP CATHETER DQY VASCULAR SOLUTIONS, INC. 5639 616765 M20656390

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention