BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 1997053 · Received February 21, 2011

    Report

    Report Number
    2024168-2011-01046
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE FIRST BMW GUIDE WIRE (PART#1001780JS-HC/LOT#0102972) IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE CUSTOMER REPORTED THE GUIDE WIRE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). RESISTANCE IN ADVANCING AND RETRACTING THE GUIDE WIRE INCLUDE, BUT ARE NOT LIMITED TO, OBSTRUCTIONS IN THE GUIDE WIRE LUMEN, CONTRAST/BLOOD BUILDUP, KINKS, BENDS, HANDLING, OR DAMAGES TO THE GUIDE WIRE OR CATHETER. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE BALLOON CATHETER. IN CERTAIN CIRCUMSTANCES, MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING ARE REQUIRED; THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL. AN ATTEMPT TO MOVE THE GUIDE 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. THE GUIDE WIRE AND THE BALLOON CATHETER WERE NOT RETURNED WHICH COULD HAVE AIDED IN THE INVESTIGATION. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED RESISTANCE IN ADVANCING AND RETRACTING THE GUIDE WIRE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A NON-ABBOTT BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED BOTH ADVANCING ON THE GUIDE WIRE AND DURING REMOVAL ON THE GUIDE WIRE. THIS OCCURRED WITH TWO BMW GUIDE WIRES IN THE SAME CASE. THE BALLOONS WERE ABLE TO BE REMOVED FROM THE GUIDE WIRES AND NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-TEMECULA-CT 0102972

    Patients

    Seq Age Sex Outcome Treatment
    1