BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2073198 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03025
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE CROSSING OR WHILE IN THE LESION WITH OTHER DEVICES MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY, LESION MORPHOLOGY, DEVICE SELECTION, DEVICE PLACEMENT TECHNIQUE, AND/OR INTERACTION BETWEEN ASSOCIATED DEVICES. OTHER FACTORS MAY ALSO CONSIST OF ANATOMICAL CONDITIONS, SUCH AS TORTUOUS VESSELS, AS THEY COULD CAUSE THE SHAPE OF THE GUIDE WIRE OR IVUS TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO ADVANCE THE IVUS OVER THE WIRE. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE IVUS. IN CERTAIN CIRCUMSTANCES, SUCH AS 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 AND COULD LEAD TO RESISTANCE. THE LESION WAS DESCRIBED AS 99% STENOSED WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTIES EXPLAINED ABOVE. THE GUIDE WIRE AND IVUS USED IN THE PROCEDURE WERE NOT RETURNED WHICH COULD HAVE AIDED IN THE EVALUATION. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTIES AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN ORDER TO ENSURE THAT THIS 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 AND PERFORMS 100% 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 THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A XIENCE STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION. THE INTRAVASCULAR ULTRA SOUND (IVUS) WAS ADVANCED ON THE BMW GUIDE WIRE; HOWEVER, THE DEVICES BECAME STUCK TOGETHER. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT, AND NO FURTHER IVUS CHECK WAS PERFORMED. IT WAS NOTED THAT IVUS WAS PREVIOUSLY PERFORMED WITH THE SAME BMW GUIDE WIRE DURING THE PROCEDURE, WITH NO DIFFICULTY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 0081271

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR STENT: XIENCE V