BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE GUIDEWIRE

    MDR report key: 2172017 · Received September 7, 2006

    Report

    Report Number
    6000130-2006-00239
    Event Type
    Injury
    Date Received
    September 7, 2006
    Date of Event
    August 9, 2006
    Report Date
    August 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS, BUT REQUIRES ADDITIONAL INVESTIGATION WHICH IS NOT COMPLETE AT THIS TIME. ADDITIONAL INFO FROM THE USER FACILITY REPORT: ZIP WIRE - STANDARD TYPE, ZIP WIRE HYDROPHILIC GUIDE WIRE, (B)(4). LOT# 02978231 OR 11975522. (B)(6).

    Description of Event or Problem · 1

    PER THE ATTACHED VOLUNTARY FACILITY MEDWATCH (PT IDENTIFIER (B)(6)), IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DISTAL COATING ON THE ZIPWIRE GUIDEWIRE WAS SHEARED OFF. WHEN THE ZIPWIRE WAS INSERTED THROUGH AN ACCESS NEEDLE, THE WIRE DOUBLED BACK ON ITSELF. WHEN THE PHYSICIAN PULLED THE ZIPWIRE BACK, IT SHEARED OFF THE DISTAL COATING. THE SHEARED PIECE REMAINED IN THE PT'S BODY AND THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE SHEARED PIECE. CURRENT PT CONDITION IS 'UNKNOWN.' ADDITIONAL INFO HAS BEEN REQUESTED ABOUT THIS EVENT. ADDITIONAL INFO FROM THE USER FACILITY REPORT: ACCORDING TO STAFF, WHEN THE ZIP WIRE WAS BEING REMOVED AFTER THE COMPLETION OF THE PT'S CARDIAC CATHETERIZATION PROCEDURE, 4MM OF THE ZIP WIRE'S HYDROPHILIC COATING CAME OFF INSIDE THE PT'S RIGHT ILIAC. PT WAS LATER TAKEN TO SURGERY. SURGEON WAS UNABLE TO REMOVE THE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE GUIDEWIRE PTA GUIDEWIRE DQX BOSTON SCIENTIFIC NA 0002978231

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R