BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 2162434 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04962
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST ON THE COILS WHICH ARE 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 ALSO NOTED THAT THE DISTAL END OF THE TIP WAS RETURNED IN A KNOT, 1 MM PROXIMAL TO THE TIP BALL. THERE WAS A BEND IN THE TIP, 2 MM PROXIMAL TO THE KNOT. THESE ARE CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICES AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ADDITIONALLY, THERE WERE FIBERS ON THE TIP COILS AT THE KNOT. THE CUSTOMER REPORTED THAT THE GUIDE WIRE WAS WIPED DOWN WITH GAUZE AFTER THE PROCEDURE, WHICH COULD HAVE LEFT FIBERS ON THE COILS. 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. QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A REVIEW OF THE LOT HISTORY RECORD FOUND NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE NOTED FIBERS ON THE COILS, THE NOTED KNOT AND BEND IN THE TIP. THESE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF THE HI-TORQUE BALANCE GUIDE WIRE, THE TIP WAS SEEN AS STRETCHED IN THE GUIDING CATHETER UNDER FLUOROSCOPY. THE BALANCE GUIDE WIRE WAS REMOVED WITHOUT DIFFICULTY. ANOTHER BALANCE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE EVALUATION FOUND FIBERS ON THE RETURNED BALANCE GUIDE WIRE. THE TIP OF THE BALANCE GUIDE WIRE WAS IN A KNOT. THE CUSTOMER REPORTED THAT THEY WIPED DOWN THE BALANCE GUIDE WIRE WITH GAUZE AFTER THE PROCEDURE, BUT THE KNOTTED TIP OCCURRED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX AV-TEMECULA-CT 0061871

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR