BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS

    MDR report key: 8391159 · Received March 5, 2019

    Report

    Report Number
    2134265-2019-02050
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729035954
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS APPROXIMATED AS EVENT DATE WAS NOT REPORTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED WITH ITS ORIGINAL BOX LABELED BATCH 22492297. THE UNIT RETURNED HAS A BENT AND UNRAVELED TIP. THERE WAS NO EVIDENCE OF A COREWIRE FRACTURE. THE OUTER DIAMETER DIMENSIONS WERE FOUND WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURED. A 018/180 PLATINUM PLUS GUIDEWIRE WAS ADVANCED TO TREAT THE LESION THROUGH A GUIDE CATHETER. HOWEVER, NEAR THE END OF THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS SEPARATING, BUT HAD NOT COMPLETELY DETACHED UPON IMAGING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED AS EVENT DATE WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURED. A 018/180 PLATINUM PLUS GUIDEWIRE WAS ADVANCED TO TREAT THE LESION THROUGH A GUIDE CATHETER. HOWEVER, NEAR THE END OF THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS SEPARATING, BUT HAD NOT COMPLETELY DETACHED UPON IMAGING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184480 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39895 0022492297 08714729035954

    Patients

    Seq Age Sex Outcome Treatment
    1