BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2183052 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05366
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST ON THE CORE, POLYMER, AND COILS 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 CONFIRMED THE REPORTED TIP SEPARATION AS THE CORE AND COILS WERE SEPARATED AT THE PROXIMAL SOLDER. THE FULL LENGTH OF THE COILS WAS 4.5 CM. THE COILS WERE RETURNED INSIDE A NON-ABBOTT GUIDING CATHETER. THERE WERE MULTIPLE KINKS IN THE SHAPING RIBBON WHICH ARE LIKELY THE RESULT OF THE SEPARATION. THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE FAILURE OF THE CORE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. FAILURE OF THE INTERMEDIATE COIL MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THE CENTER SOLDER WAS INTACT AND THE TIP BALL WAS MISSING. GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. IN THIS CASE, IT WAS REPORTED THAT THE GUIDE WIRE TIP USED IN THE DIAGONAL ARTERY MUST HAVE BEEN SEPARATED DURING RETRACTING. CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY A CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT THE PROCEDURE DOES NOT MATCH THE INCIDENT DESCRIPTION IN THAT NO STENT WAS DEPLOYED IN THE DIAGONAL BRANCH. THERE IS NO IMAGE SHOWING RADIOPACITY AT THE TIP OF THE GUIDING CATHETER NOT VISIBLE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY OR DIAGONAL ARTERY. THUS, THE INCIDENT CANNOT BE CONFIRMED THROUGH CINE. IN ORDER TO ENSURE THAT GUIDE WIRE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. THE ANALYSIS OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: DIL CATH: 2.5 X 15 MAVERICK; GUIDE WIRE: BMW UNIVERSAL II; STENT: 3.0 X 23 XIENCE PRIME, 3.0 X 15 XIENCE PRIME. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AREA TO BE TREATED WAS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II WAS PLACED IN THE LAD AND ONE BMW UNIVERSAL II WAS PLACED IN THE DIAGONAL ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM NON-ABBOTT BALLOON IN THE DIAGONAL ARTERY, WITHOUT ANY ISSUE, AND A XIENCE PRIME 3.0 X 23 MM WAS IMPLANTED SUCCESSFULLY IN THE DIAGONAL ARTERY. THE GUIDE WIRE WAS THEN RETRACTED, WITH NO RESISTANCE, OUT OF THE DIAGONAL ARTERY (NO CALCIFICATION WAS PRESENT IN VESSEL) AND A XIENCE PRIME 3.0 X 15 MM WAS ATTEMPTED TO BE PLACED IN THE LAD. WHEN THE XIENCE PRIME 3.0 X 15 MM WAS ADVANCED THROUGH THE GUIDING CATHETER, A RADIOPAQUE PIECE WAS NOTED AT THE DISTAL END OF THE GUIDING CATHETER. THE XIENCE PRIME WAS RETRACTED AND THE RADIOPAQUE PIECE WAS NOTED TO HAVE MOVED BACK INTO THE GUIDING CATHETER AS WELL. THE WHOLE SYSTEM (GUIDING CATHETER WITH THE XIENCE PRIME AND THE RADIOPAQUE PIECE INSIDE) WAS THEN REMOVED FROM THE PATIENT. AFTER REMOVAL, THE GUIDING CATHETER WAS INSPECTED AND IT WAS NOTED THAT THE TIP OF THE BMW UNIVERSAL II REMAINED INSIDE THE GUIDING CATHETER. IT WAS CONCLUDED THAT THE TIP OF THE BMW UNIVERSAL II USED IN THE DIAGONAL ARTERY MUST HAVE SEPARATED DURING THE RETRACTING. THE BMW UNIVERSAL II WHICH HAD BEEN PREVIOUSLY PLACED IN THE LAD HAD NOT SEPARATED AND WAS STILL POSITIONED IN THE VESSEL. THEREFORE, THE GUIDING CATHETER WAS EASILY CHANGED AND THE XIENCE PRIME 3.0 X 15 MM WAS IMPLANTED IN THE LAD WITH A GOOD RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 1041873

    Patients

    Seq Age Sex Outcome Treatment
    1