BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2251762 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06371
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: MUTLILINK ZETA, VISION. GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II. (B)(4) - AGAINST RESISTANCE AND EXCESSIVE FORCE. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE IN THE LESION MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY, LESION MORPHOLOGY, DEVICE SELECTION, DEVICE PLACEMENT TECHNIQUE, AND/OR INTERACTION BETWEEN ASSOCIATED DEVICES. IN CERTAIN CIRCUMSTANCES, SUCH AS MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. THE GUIDE WIRE WAS ENTRAPPED BETWEEN THE MULTILINK ZETA STENT AND THE VESSEL WALL WHICH CONTRIBUTED TO THE REPORTED DIFFICULTY RETRACTING THE GUIDE WIRE. ADDITIONALLY, THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. REPORTEDLY, SEVERAL ATTEMPTS WERE MADE TO WITHDRAW THE GUIDE WIRE WITH FORCE AND THE GUIDE WIRE SEPARATED WITH THE SEPARATED PIECE REMAINING IN THE RIGHT CORONARY ARTERY. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE, WARNINGS SECTION STATES: 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. IT APPEARS THAT WITHDRAWING THE GUIDE WIRE WITH FORCE WHEN RESISTANCE WAS MET LIKELY CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, PERFORMS A NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS A 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE REPORTED DIFFICULTY RETRACTING THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO USER ERROR. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO RELATED INCIDENTS. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS ADVANCED INTO THE PATIENT ANATOMY. A SECOND BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS THEN ADVANCED TO REINFORCE THE SUPPORT. A MULTILINK ZETA STENT SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS DEPLOYED IN THE HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY. THE MULTILINK ZETA STENT SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY. A VISION STENT SYSTEM WAS THEN ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS DEPLOYED IN THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. AFTER THE STENTS WERE DEPLOYED, AN ATTEMPT WAS MADE TO WITHDRAW ONE OF THE BALANCE MIDDLEWEIGHT GUIDE WIRES; HOWEVER, THE GUIDE WIRE WAS ENTRAPPED BETWEEN THE MULTILINK ZETA STENT AND THE VESSEL WALL AND COULD NOT BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO WITHDRAW THE GUIDE WIRE WITH FORCE AND THE GUIDE WIRE SEPARATED, WITH THE SEPARATED PIECE REMAINING IN THE RIGHT CORONARY ARTERY. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE SEPARATED SEGMENT OF THE GUIDE WIRE REMAINING IN THE PATIENT ANATOMY. THE OTHER PART OF THE SEPARATED SEGMENT WAS PULLED FROM THE PATIENT ANATOMY. THE SECOND BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT SEQUELAE. 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 1051171

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other