BEUDAMED
    FDA Adverse Event Injury Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 1972023 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00493
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: GLIDEWIRE, HT WINN 80; OTHER: QUICKCROSS (MICROCATHETER). ALTHOUGH THE GUIDE WIRE WAS NOT RETURNED FOR INVESTIGATION, TYPICALLY A SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED, WHICH IN THIS CASE, APPEARS TO HAVE BEEN WITHIN THE FALSE LUMEN (DISSECTION AREA). IT MAY BE POSSIBLE THAT PUSHING AGAINST RESISTANCE WITHIN THE FALSE LUMEN CAUSED THE TIP TO PROLAPSE AND BECOME LODGED IN THE VESSEL. THIS PROLAPSE MAY POSSIBLY CAUSE STRESS TO CORE MATERIAL AND UPON REMOVAL, THIS PORTION OF THE TIP MAY ULTIMATELY SEPARATE. THERE WAS NO ATTEMPT TO REMOVE THE DISTAL TIP FROM FALSE LUMEN. BASED ON THE CASE DESCRIPTION, IT APPEARS THAT THE DISSECTION MAY HAVE OCCURRED DURING THE INITIAL USE OF THE NON-ABBOTT GUIDE WIRE AS IT WAS REPORTED THAT THE WIRE WAS EXCHANGED TO THE WINN 200 GUIDE WIRE AND WHILE ADVANCING, IT WENT INTO A FALSE LUMEN AND BECAME STUCK. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. OVERALL, THE REPORTED TIP ENTRAPMENT, TIP SEPARATION AND VESSEL DISSECTION APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A TIP PULL TEST IS PERFORMED ON EACH GUIDE WIRE TO ENSURE THE TIP IS PROPERLY ATTACHED. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTAL OCCLUSION, APPROXIMATELY 5 TO 6 CM IN LENGTH, IN THE POPLITEAL VESSEL. A NON-ABBOTT GUIDE WIRE WAS FIRST ABLE TO GET ACROSS WITH A MICROCATHETER. THEN A WINN 80 GUIDE WIRE WAS USED AND ABLE TO GET THROUGH THE PROXIMAL CAP OF THE OCCLUSION. THE DECISION WAS MADE TO EXCHANGE FOR THE WINN 200 GUIDE WIRE. AS THIS GUIDE WIRE WAS ADVANCING, IT WENT INTO A FALSE LUMEN AND BECAME STUCK. THE GUIDE WIRE WAS FINALLY ABLE TO BE PULLED BACK; HOWEVER, THE DISTAL TIP SEPARATED AND REMAINED IN THE FALSE LUMEN. THERE WERE NO RETRIEVAL ATTEMPTS. ONE MORE NON-ABBOTT GUIDE WIRE WAS USED, BUT COULD NOT GET THROUGH THE OCCLUSION. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD GOOD 3 VESSEL BLOOD FLOW IN THE LEG AND ENDED THE PROCEDURE. THE PHYSICIAN ALSO REPORTED THAT HE NEVER TURNED THE WIRE MORE THAN 180 DEGREES; THEREFORE, IT IS UNKNOWN WHY THE GUIDE WIRE SEPARATED. THERE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0090901

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other