BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS

    MDR report key: 8531480 · Received April 19, 2019

    Report

    Report Number
    2134265-2019-04131
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 27, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729114567
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. UNIT RETURNED WITH ITS ORIGINAL BOX. THE UNIT RETURNED HAS TIP DAMAGE, AS PART OF OVERALL VISUAL REVISION. THE GUIDEWIRE RETURNED WITH THE DISTAL SECTION UNRAVELED AND WITH COREWIRE BENT AT DISTAL END. NO EVIDENCE OF COREWIRE FRACTURED . THE OUTER DIAMETER DIMENSIONS WERE FOUND WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ENTRAPMENT OF DEVICE OCCURRED. THE ALMOST OCCLUDED AND STENOSED TARGET LESION WAS LOCATED IN AN ARTERY IN THE RIGHT LEG. A 018/180 PLATINUM PLUS-3 GUIDEWIRE WAS ADVANCE FOR USE. THE PHYSICIAN TRIED TO RECANALIZE THE CALCIFIED LESION WITH BACK AND FORTH MOVEMENT, HOWEVER THE TIP OF THE WIRE GOT STUCK IN THE LESION. THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE BACK, BUT IT STUCK VERY TIGHTLY WITHIN THE LESION. DURING THE REMOVAL ATTEMPT THE GUIDEWIRE MOVED BACK AND THE WIRE STARTED TO FRAY AS THE TIP REMAINED STUCK IN THE LESION. THE DEVICE WAS COMPLETELY TAKEN OUT FROM THE PATIENT. THE PROCEDURE IS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENTRAPMENT OF DEVICE OCCURRED. THE ALMOST OCCLUDED AND STENOSED TARGET LESION WAS LOCATED IN AN ARTERY IN THE RIGHT LEG. A 018/180 PLATINUM PLUS-3 GUIDEWIRE WAS ADVANCE FOR USE. THE PHYSICIAN TRIED TO RECANALIZE THE CALCIFIED LESION WITH BACK AND FORTH MOVEMENT, HOWEVER THE TIP OF THE WIRE GOT STUCK IN THE LESION. THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE BACK, BUT IT STUCK VERY TIGHTLY WITHIN THE LESION. DURING THE REMOVAL ATTEMPT THE GUIDEWIRE MOVED BACK AND THE WIRE STARTED TO FRAY AS THE TIP REMAINED STUCK IN THE LESION. THE DEVICE WAS COMPLETELY TAKEN OUT FROM THE PATIENT. THE PROCEDURE IS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325826 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39935 0022524872 08714729114567

    Patients

    Seq Age Sex Outcome Treatment
    1