BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PLUS PTCA GUIDEWIRE

    MDR report key: 1871891 · Received October 16, 2010

    Report

    Report Number
    2134265-2010-04534
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE KINETIX PLUS STR GUIDEWIRE WAS RECEIVED WITH NO ORIGINAL PACKAGING AND THE VERIFLEX SDS (STENT DELIVERY SYSTEM), NO OTHER ACCESSORY DEVICES WERE RETURNED FOR ANALYSIS. THE KINETIX WIRE WAS RECEIVED STUCK WITHIN THE SDS, ~ 12.5 IN OF THE WIRE REMAINED OUTSIDE OF THE DISTAL TIP. THE WIRE WAS NOT ABLE TO BE REMOVED FROM THE SDS WHEN PULLED FROM EITHER END (PROXIMAL OR DISTAL) WITH CONSIDERABLE FORCE. VISUAL AND MICROSCOPIC INSPECTION OF CATHETER OUTER LUMEN SHOWED EVIDENCE OF DRIED BLOOD/CONTRAST MEDIA PRESENT BETWEEN THE CATHETER AND GUIDEWIRE, IN ATTEMPT TO LOOSEN THE MEDIA THE DEVICE WAS SOAKED IN A CIRCULATING BATH FOR A PERIOD OF 24 HOURS; AFTER SOAKING IT WAS STILL NOT POSSIBLE TO REMOVE THE WIRE FROM THE DEVICE. THE UNIT WAS CUT WITH A RAZOR BLADE LONGITUDINALLY, ONCE CUT LARGE AMOUNTS OF VERY DARK MEDIA (DRIED BLOOD) COULD BE SEEN BETWEEN THE WIRE AND INNER LUMEN. NO OTHER IRREGULARITIES WERE NOTED. 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 MFR# 2134265-2010-04533. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDEWIRE. A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE UNSPECIFIED LESION ALONG WITH A 4.50X28MM VERIFLEX STENT. THE VERIFLEX STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE GUIDEWIRE CAME WITH IT AS BOTH DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-04533. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDEWIRE. A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE UNSPECIFIED LESION ALONG WITH A 4.50X28MM VERIFLEX STENT. THE VERIFLEX STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE GUIDEWIRE CAME WITH IT AS BOTH DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122040

    Patients

    Seq Age Sex Outcome Treatment
    1 4.50X28MM VERIFLEX STENT