BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 1903811 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02475
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALLOON CATHETER FOUND BLOOD AND CONTRAST IN THE HUB, GUIDE WIRE LUMEN, AND INFLATION LUMEN, WHICH IS CONSISTENT WITH THE DEVICE BEING USED INSIDE THE BODY. THE BALLOON WAS TIGHTLY FOLDED, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE BALLOON WAS NOT INFLATED. THE DISTAL SHAFT OF THE CATHETER WAS STRETCHED AT THE GUIDE WIRE EXIT NOTCH AND THERE WAS A TEAR IN THE INNER AND OUTER MEMBER AT THE GUIDE WIRE EXIT NOTCH. THE DISTAL END OF THE RETURNED BMW UNIVERSAL II GUIDE WIRE WAS RETURNED FROZEN IN THE GUIDE WIRE LUMEN. THE CORE OF THE GUIDE WIRE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE AND ONLY 40 CM WAS RETURNED. THERE WAS A KINK IN THE CORE 5 CM DISTAL TO THE CORE SEPARATION. THE CORE WAS CORKSCREWED BETWEEN THE SEPARATION AND THE KINK. GUIDE WIRE SEPARATIONS MAY OCCUR WHEN THE DISTAL END IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL END TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE GUIDE WIRE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. IN THIS CASE, THE REMAINING PORTION OF THE GUIDE WIRE WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED IN THE EVALUATION. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE WIRE TO BE TRAPPED, POSSIBLY WITHIN ANOTHER DEVICE OR IN THE ANATOMY IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. ANY ATTEMPTS TO MOVE THE GUIDE WIRE IN A TRAPPED STATE WOULD HAVE THEN LIKELY RESULTED IN THE REPORTED GUIDE WIRE SEPARATION. WHILE THERE WAS NO REPORTED RESISTANCE IT IS POSSIBLE THERE WAS INTERACTION BETWEEN THE GUIDE WIRE AND CATHETER AS THE WIRE WAS RETURNED FROZEN INSIDE OF THE GUIDE WIRE LUMEN. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. IN CERTAIN CIRCUMSTANCES, SUCH AS DURING HIGH PRESSURE BALLOON INFLATIONS, 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. AN ATTEMPT TO MOVE THE WIRE IN THIS REDUCED CLEARANCE CONDITION CAN CAUSE THE COILS TO BUNCH UP, INCREASING THE DIAMETER OF THE GUIDE WIRE, WHICH IN THE EXTREME CONDITION CAN CAUSE COIL OVERLAP. IF THE RESISTANCE IS NOT REDUCED AND CONTINUED FORCE IS APPLIED TO THE SYSTEM, THE RESULT IS PERMANENT DEFORMATION OF THE WIRE AND/OR GUIDE WIRE LUMEN. NO DAMAGE TO EITHER DEVICE WAS REPORTED PRIOR TO USE, WHICH WOULD INDICATE THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. IN ORDER TO ENSURE THAT GUIDE WIRE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A NON DESTRUCTIVE PULL TEST ON EACH WIRE, AND PERFORMS 100% OUTER DIAMETER INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE KINK NOTED DURING ANALYSIS IS LIKELY THE RESULT OF THE PROCEDURE OR FROM HANDLING AFTER THE PROCEDURE AS THERE WAS NO GUIDE WIRE DAMAGE NOTED PRIOR TO THE PROCEDURE. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED. IN THIS CASE, BASED ON THE REPORTED INFORMATION A CONCLUSIVE CAUSE FOR THE GUIDE WIRE DAMAGE COULD NOT BE DETERMINED, HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BMW UNIVERSAL II GUIDE WIRE WITH THE VOYAGER CATHETER, THE GUIDE WIRE BECAME SEPARATED. THE VOYAGER BALLOON WAS PLACED IN DIAGONAL BRANCH WHEN BLOOD CAME BACK INTO THE INFLATION DEVICE. THE BALLOON WAS NEVER INFLATED. (ANOTHER BALLOON WAS BEING POSITIONED INTO THE LEFT ANTERIOR DESCENDING (LAD) BEFORE INFLATING IN AN ATTEMPT TO PERFORM A "KISSING BALLOON" TECHNIQUE.) WHEN THE VOYAGER WAS BEING REMOVED, THE GUIDE WIRE SEPARATED. IT IS UNKNOWN IF ANY RESISTANCE WAS FELT. THE ENTIRE GUIDE WIRE WAS REMOVED FROM THE PATIENT INSIDE THE VOYAGER CATHETER. A NEW GUIDE WIRE AND A NON-ABBOTT BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR