BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS?

    MDR report key: 3864387 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03503
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA (B)(4) THAT THE GUIDEWIRE WAS SNARED OUT OF THE VESSEL. ACCESS WAS OBTAINED VIA THE RIGHT ARM. A 025/180 PLATINUM PLUS¿ GUIDEWIRE WAS ADVANCED TO THE LESION. IT WAS NOTED THAT THE DEVICE UNCOILED IN AN UNSPECIFIED VEIN. THE DEVICE WAS ABLE TO BE SNARED AND WAS REMOVED FROM THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340990 PLATINUM PLUS? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001466100 16377724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention