BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRES

    MDR report key: 1213672 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03118
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE DE NOVO LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS VESSEL. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. UPON ATTEMPTING TO ROTATE AND ADVANCE THE CHOICE FLOPPY GUIDE WIRE, THE GUIDE WIRE BECAME STUCK IN THE CALCIFIED VESSEL AND WAS DIFFICULT TO REMOVE. AFTER REMOVAL OF THE GUIDE WIRE, THE PHYSICIAN NOTED SOME DAMAGE BETWEEN THE FLEXIBLE TIP AND GUIDE WIRE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND AN UNSPECIFIED STENT WAS IMPLANTED. THERE WERE NO PT INJURIES OR COMPLICATIONS. THE PT'S STATUS WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC CORPORATION CHOICE FLOP (5PK) 11890987

    Patients

    Seq Age Sex Outcome Treatment
    1 70+