BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 2001387 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01181
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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. RESISTANCE WITH THE ANATOMY CAN OCCUR DUE TO, BUT NOT LIMITED TO, LESION CHARACTERISTICS AND ANATOMICAL MORPHOLOGY OF THE PATIENT. ANATOMICAL INFORMATION WAS NOT PROVIDED WHICH COULD HAVE AIDED IN THE EVALUATION. FOR THE GUIDE WIRE TO FAIL IN THIS MANNER THE GUIDE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING OR OVER TORQUED 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. ANY ATTEMPTS TO MOVE THE GUIDE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. IT WAS REPORTED THAT RESISTANCE WAS FELT DURING REMOVAL AND THE GUIDE WIRE SEPARATED. INSTRUCTIONS FOR USE (IFU) 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. IN THIS CASE, THE REPORTED GUIDE WIRE SEPARATION IS MOST LIKELY THE RESULT OF THE REPORTED RESISTANCE OF THE GUIDE WIRE WITH THE LESION DURING REMOVAL. THE GUIDE WIRE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. OVERALL, THE REPORTED GUIDE WIRE TIP SEPARATION, FOREIGN BODY IN PATIENT, ADDITIONAL THERAPY/NON-SURGICAL PROCEDURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED RESISTANCE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, PERFORMS 100% VISUAL INSPECTION AND PERFORMS 100% OUTER DIAMETER INSPECTION 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 THE RESISTANCE WAS FELT DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE FROM THE RIGHT CORONARY ARTERY, WHICH RESULTED IN THE TIP OF THE GUIDE WIRE SEPARATING IN THE ANATOMY. THE SEPARATED TIP WAS COMPRESSED AGAINT THE VESSEL WALL WITH THE PLACEMENT OF A STENT. ALTHOUGH SURGERY IS PLANNED ON ANOTHER ARTERY; THE DECISION WAS MADE TO LEAVE THE SEPARATED TIP IN THE PATIENT. THE PATIENT IS REPORTED TO BE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0081972

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention