BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2101259 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03672
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. STENT: 3.0 X 28 MM OTW XIENCE V; OTHER: XPORT THROMBECTOMY DEVICE. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST ON THE ENTIRE LENGTH OF THE GUIDE WIRE WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS COULD NOT CONFIRM THE REPORTED RESISTANCE WITH THE STENT DELIVERY SYSTEM DUE TO THE CONDITION OF THE RETURNED GUIDE WIRE. ANALYSIS ALSO NOTED THAT THE OUTER DIAMETER OF THE SOLDER JOINTS WERE MEASURED WITH A HOLE GAUGE AND MET MANUFACTURING CRITERIA. THE OUTER DIAMETER OF THE GUIDE WIRE PROXIMAL TO THE HYPOTUBE SEPARATION WAS MEASURED WITH A LASER MICROMETER AND MET MANUFACTURING CRITERIA. RESISTANCE BETWEEN DEVICES, SUCH AS THE REPORTED GUIDE WIRE AND THE STENT DELIVERY SYSTEM, CAN OCCUR DUE TO NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, INTERACTION WITH OTHER DEVICES, REMOVAL TECHNIQUE, LESION MORPHOLOGY, PATIENT ANATOMY/DISEASE STATE, THE CONDITION OF THE CATHETER BEING USED, AND/OR CONDITION OF WIRE COATING. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER OR ON THE WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. ANALYSIS NOTED THAT THE CORE WAS SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THERE WAS CORE VISIBLE IN THE HYPOTUBE AT THE SEPARATION. THE SEPARATED PORTION WAS RETURNED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. IT WAS NOTED THAT THERE WAS CORE EXTENDING OUT THE HYPOTUBE, INDICATING THE HYPOTUBE WAS PROPERLY ATTACHED TO THE CORE. A HYPOTUBE BEING OVER PULLED OR OVER BENT WOULD REQUIRE IT TO BE TRAPPED WITHIN THE LESION ANATOMY AND/OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO CAUSE A SEPARATION. IT IS POSSIBLE THAT DURING REMOVAL OF THE WIRE FROM THE DISPENSER HOOP, OR PREPARATION OF THE WIRE PRIOR TO USE, THAT A BEND COULD OCCUR THAT WOULD LATER FRACTURE. IN THIS CASE, IT WAS REPORTED THAT RESISTANCE WAS FELT DURING REMOVAL OF THE STENT DELIVERY SYSTEM WHICH COULD HAVE CONTRIBUTED TO THE NOTED GUIDE WIRE SEPARATION. THE STENT DELIVERY SYSTEM WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. NO DAMAGE TO THE WIRE WAS NOTED DURING INSPECTION PRIOR TO USE, WHICH WOULD INDICATE THAT THE WIRE DAMAGE WAS LIKELY NOT PRE-EXISTING. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED RESISTANCE AND THE NOTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WAS NO NONCONFORMING MATERIAL RECORD ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENT INTERVENTIONAL PROCEDURE OF THE MID LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS PLACED AND THE THROMBECTOMY DEVICE WAS USED, BUT IT WAS NOTED THAT DURING RETRACTING THE DEVICE THE GUIDE WIRE FELT GRAINY AND NOT SMOOTH, BUT IT DID NOT STICK TO THE DEVICE AND WAS REMOVED WITHOUT INCIDENT. A 3.0 X 28 MM OTW XIENCE V WAS ADVANCED AND DEPLOYED WITHOUT INCIDENT. DURING REMOVAL OF THE STENT DELIVERY SYSTEM RESISTANCE WAS MET AND THE GUIDE WIRE WAS VERY STICKY, SO THE DEVICES WERE REMOVED TOGETHER AS A SYSTEM. A SHORT BMW WAS PLACED AND THE PROCEDURE COMPLETED WITHOUT EVENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0121871

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR