BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2031989 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02075
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    April 1, 2010
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(4) - EXCESSIVE FORCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST ON THE COILS, POLYMER COATING AND CORE, WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ANALYSIS ALSO NOTED STRETCHED TIP COILS 1.9 CM DISTAL TO THE CENTER SOLDER, WHICH IS LIKELY THE RESULT OF THE REPORTED GUIDE WIRE SEPARATION AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. THERE WAS A KINK IN THE CORE, 36.5 CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THERE WAS A BEND IN THE CORE, 46.8 CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THESE NOTED DAMAGES ARE CONSISTENT WITH PRODUCT HANDLING DURING THE PROCEDURE AND/OR PACKAGING DURING SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. THE STENT DELIVERY SYSTEM USED IN THE PROCEDURE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE EVALUATION. ANALYSIS DID CONFIRM THE REPORTED GUIDE WIRE SEPARATION AS THE SHAPING RIBBON WAS SEPARATED, 2.8 CM DISTAL TO THE CENTER SOLDER. THE SEPARATED PORTION WAS NOT RETURNED. THE STENT DELIVERY SYSTEM (SDS) USED IN THE PROCEDURE WAS NOT RETURNED. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE FAILURE OF THE SHAPING RIBBON AND COIL MAY BE ATTRIBUTED TO DIMPLE RUPTURE, TENSILE OVERLOAD. THE SHAPING RIBBON AND COIL EXHIBITED NECKING AT THE FRACTURED ENDS. FOR FAILURE OF THIS MANNER, THE GUIDE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING OR OVER TORQUING BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE GUIDE WIRE AS DESCRIBED. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. NO DAMAGE TO THE GUIDE WIRE TIP WAS REPORTED PRIOR TO USE, WHICH COULD INDICATE THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. IN THIS CASE, IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE MOVED FORWARD OR BACKWARD THROUGH THE STENT DELIVERY SYSTEM AND FORCE WAS APPLIED WHILE PULLING BACK ON THE GUIDE WIRE AND THE GUIDE WIRE SEPARATED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: DO NOT: 1) PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. 2) TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. 3) 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, WHEN FORCE WAS APPLIED TO THE GUIDE WIRE, RESISTANCE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. REPORTEDLY, SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE FROM THE ANATOMY AND A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE OCCURRED. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INABILITY TO ADVANCE AND RETRACT THE SDS OVER THE GUIDE WIRE. THE REPORTED GUIDE WIRE SEPARATION AND TREATMENT TO RETRIEVE THE SEPARATED PORTION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND IMPROPER USER TECHNIQUE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. ALL GUIDE WIRES ARE VISUALLY INSPECTED FOR DAMAGE DURING MANUFACTURING, 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 THE PROCEDURE AT THE BIFURCATION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND THE MARGINAL ARTERY, A BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) GUIDE WIRE WAS ADVANCED. OUTSIDE OF THE ANATOMY, THE GUIDE WIRE WAS INSERTED INTO A XIENCE PRIME STENT SYSTEM. THE STENT SYSTEM WAS ADVANCED ON THE GUIDE WIRE INTO THE ANATOMY. POST STENT DEPLOYMENT, THE GUIDE WIRE COULD NOT BE MOVED FORWARD OR BACKWARD THROUGH THE STENT SYSTEM. FORCE WAS APPLIED WHILE PULLING BACK ON THE GUIDE WIRE AND THE GUIDE WIRE SEPARATED IN TWO PIECES; ONE SEGMENT IN THE PHYSICAN'S HAND AND THE OTHER SEGMENT IN THE ANATOMY. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE APPROXIMATELY 23 CM OF THE GUIDE WIRE. (THE GUIDE WIRE WAS OBSERVED BY THE AV ACCOUNT MANAGER AND APPROXIMATELY 2 CM OF THE GUIDE WIRE TIP WAS MISSING). A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE OCCURRED. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 0022401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XIENCE PRIME STENT SYSTEM