BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THRUWAY GUIDE WIRES

    MDR report key: 2008909 · Received March 7, 2011

    Report

    Report Number
    2134265-2011-00522
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K760944. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-00500, 2134265-2011-00632. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. IN 2002, AN UNSPECIFIED NIROYAL STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY. FURTHER LESION CHARACTERISTICS, CLINICAL FACTORS AND PATIENT IMPACT ARE UNKNOWN. IN 2011, THE PATIENT PRESENTED WITH OSTIAL STENOSIS. THE 80% STENOSED, CONCENTRIC, 5X 5MM FOCAL LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS OSTIAL LEFT RENAL ARTERY. THE PHYSICIAN ATTEMPTED TO USE A 5.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON, BUT WAS UNABLE TO CROSS THE LESION. THE CUTTING BALLOON WAS REMOVED AND A 5.0X15MM STERLING BALLOON WAS INSERTED. UPON REMOVAL OF THE STERLING BALLOON, THE PREVIOUSLY IMPLANTED NIROYAL STENT WAS EXPLANTED. THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO SNARE THE NIROYAL STENT BUT WAS UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO PULL THE STENT INTO THE TRACT OF THE LEFT FEMORAL ACCESS POINT, BUT WAS UNABLE TO REMOVE THE STENT FROM THIS LOCATION. DURING THE REMOVAL ATTEMPT THE TIP OF THE UNSPECIFIED SIZE THRUWAY GUIDEWIRE FRACTURED AND ALSO REMAINED IN THE TISSUE TRACT OF THE LEFT FEMORAL ACCESS POINT. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE STENT AND PORTION OF THE GUIDEWIRE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THRUWAY GUIDE WIRES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE UNK591

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Required Intervention 5.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON| 5.0X15/80 STERLING BALLOON