BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2031857 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02061
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALANCE MIDDLEWEIGHT GUIDE WIRE NOTED BLOOD ON THE COILS AND THERE WAS NO CONTRAST VISIBLE 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 ALSO NOTED A BEND IN THE TIP PROXIMAL TO THE TIP BALL AND THERE WAS A KINK IN THE CORE AT THE DISTAL END OF THE CENTER SOLDER WHICH IS CONSISTENT WITH INTERACTION WITHIN THE LESION ANATOMY AND/OR OTHER DEVICE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS CORE MATERIAL VISIBLE AT THE SEPARATION IN THE DISTAL END OF THE HYPOTUBE. THE ENTIRE LENGTH OF THE CORE PROXIMAL TO THE PROXIMAL SOLDER WAS IN A CORKSCREW SHAPE WHICH IS LIKELY THE RESULT OF THE GUIDE WIRE SEPARATION. RESISTANCE BETWEEN AN IVUS CATHETER AND THE GUIDE WIRE CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, A DAMAGED GUIDE WIRE, CONDITION OF THE WIRE COATING, PATIENT ANATOMICAL MORPHOLOGY, WIRE MANIPULATION TECHNIQUE, AND/OR LESION CHARACTERISTICS. IN SOME INSTANCES, SUCH AS DURING MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING, AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCE BETWEEN THE GUIDE WIRE AND THE IVUS CATHETER CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND CAUSE RESISTANCE BETWEEN DEVICES. COAGULATION OF BLOOD OR CONTRAST CAN ALSO BE A FACTOR IN REDUCING CLEARANCE. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTY AS EXPLAINED ABOVE. REPORTEDLY, RESISTANCE WAS MET BETWEEN THE GUIDE WIRE AND THE IVUS AND FORCE WAS APPLIED TO WITHDRAW ALL OF THE EQUIPMENT AS A SYSTEM TOGETHER AND IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) WARNINGS SECTION: DO NOT: PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. IN THIS CASE, THE REPORTED GUIDE WIRE SEPARATION IS LIKELY THE RESULT OF THE FORCE APPLIED WHEN RESISTANCE WAS MET DURING REMOVAL OF THE DEVICES. SCANNING ELECTRON MICROSCOPE (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. FOR THE WIRE TO FAIL IN THIS MANNER THE HYPOTUBE BEING OVER PULLED OR OVER BENT WOULD REQUIRE IT TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCED TO CAUSE A SEPARATION. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN PRODUCTS CAN ALL BE FACTORS. IT IS POSSIBLE THAT THE GUIDE WIRE SEPARATION IS LIKELY THE RESULT OF THE FORCE APPLIED DURING REMOVAL OF THE DEVICES FROM THE ANATOMY. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR GUIDE WIRE SEPARATION, DIFFICULT TO REMOVE, USE ERROR AND STRETCHED TIP FOR THIS LOT. OVERALL, THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE THE RESULT OF THE USER IMPROPER PROCEDURE. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED RESISTANCE BETWEEN THE GUIDE WIRE AND THE IVUS. THE REPORTED CORKSCREW SHAPE OF THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE HYPOTUBE JUNCTION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS BEING USED WITH AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER AND AN ATTEMPT WAS MADE TO EXCHANGE THE GUIDE WIRE, BUT THE IVUS COULD NOT BE MOVED INDEPENDENTLY. FORCE WAS USED TO WITHDRAW ALL OF THE EQUIPMENT AS A SYSTEM TOGETHER. ONCE REMOVED OUTSIDE THE ANATOMY, THE BMW WAS NOTED TO BE 'CORKSCREW SHAPE' AND UNRAVELED APPROXIMATELY 10-15CM FROM THE TIP. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 0122971

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRAVASCULAR ULTRASOUND CATHETER