BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS

    MDR report key: 8302713 · Received February 4, 2019

    Report

    Report Number
    2134265-2019-00737
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    December 31, 2018
    Report Date
    March 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729114567
    PMA / PMN Number
    K935997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE SPRING TIP WAS DAMAGED. THE DAMAGE WAS IN THE FORM OF UNRAVELING, AND THE CORE WIRE WAS FRACTURED AT THE DISTAL END. DIMENSIONAL INSPECTION REVEALED THE OUTER DIAMETERS OF THE DEVICE PROXIMAL, MIDDLE, AND TIP SECTIONS WERE ALL WITHIN SPECIFICATIONS. APART FROM THE OBSERVED DAMAGE, INSPECTION PRESENTED NO OTHER ISSUES OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERY OF THE FOOT. A 018/180 PLATINUM PLUS GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, AFTER DILATION OF THE VESSEL, THE TIP OF THE GUIDEWIRE BROKE BETWEEN 5 AND 7CM AND REMAINED IN THE VESSEL. THE ARTERY IS NOT VERY PERMEABLE PER DOPPLER. AN ATTEMPT TO RECOVER THE BROKEN TIP BY LASSO WAS PERFORMED, BUT IT TURNED OUT TO BE IMPOSSIBLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERY OF THE FOOT. A 018/180 PLATINUM PLUS GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, AFTER DILATION OF THE VESSEL, THE TIP OF THE GUIDEWIRE BROKE BETWEEN 5 AND 7CM AND REMAINED IN THE VESSEL. THE ARTERY IS NOT VERY PERMEABLE PER DOPPLER. AN ATTEMPT TO RECOVER THE BROKEN TIP BY LASSO WAS PERFORMED, BUT IT TURNED OUT TO BE IMPOSSIBLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96355 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39935 0022446043 08714729114567

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention