BEUDAMED
    FDA Adverse Event Other Summary report: N

    BERENSTEIN 1 5-100 .035 WB

    MDR report key: 191639 · Received October 8, 1998

    Report

    Report Number
    1628221-1998-00058
    Event Type
    Other
    Date Received
    October 8, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 10, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CATHETER WAS BEING UTILIZED FOR A STENT VISUALIZATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. DURING THE ATTEMPT TO ADVANCE AND TORQUE THE CATHETER AROUND A LESION IN THE RIGHT POPLITEAL ARTERY, THE PHYSICIAN NOTICED THAT THE CATHETER TORQUED FREELY AT THE HUB, BUT UNDER FLUOROSCOPY. NOTHING APPEARED TO BE HAPPENING AT THE TIP. THE ENTIRE CATHETER WAS VIEWED UNDER FLUOROSCOPY AND APPEARED TO BE INTACT WITH NO FRACTURE SEEN. AN ATTEMPT TO REMOVE THE CATHETER RESULTED IN THE EXTRACTION OF ONLY THE TRAILING 1/3 OF THE CATHETER. THE FRACTURE APPEARED IRREGULAR AND WAS CONSIDERED TO HAVE OCCURRED IN THE LEFT ILIAC ARTERY. THE LEADING PORTION OF THE CATHETER WAS RETRIEVED WITH A SNARE DEVICE AND THE PT WAS REPORTED TO BE STABLE AND UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERENSTEIN 1 5-100 .035 WB DIAGNOSTIC INTRAVASCULAR CATHETER DQO MALLINCKRODT MEDICAL, INC. NA M411000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R INTRODUCER AND AN| 2) EXCHANGE LENGTH .035 GUIDEWIRE.| 1) 7 FRENCH COOK BALKIN UP AND OVER CONTRALATERAL