BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 2082306 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03321
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED HI TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE NOTED BLOOD AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ANALYSIS NOTED THAT THE SHAPING RIBBON WAS SEPARATED, 6 MM PROXIMAL TO THE TIP BALL. THE TIP COILS WERE COMPLETELY STRETCHED OUT DISTAL TO THE CENTER SOLDER UP TO THE SHAPING RIBBON SEPARATION. THE TIP BALL WAS STILL ATTACHED TO THE COILS AND THE SEPARATED PORTION OF THE SHAPING RIBBON. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE SHAPING RIBBON FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. A GUIDE WIRE SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL END TO DETACH. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED 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. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING REMOVAL, THE GUIDE WIRE BECAME STUCK IN THE VESSEL WHICH COULD CONTRIBUTE TO THE NOTED GUIDE WIRE TIP SEPARATION. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE RETRACTING OR WHILE IN THE LESION 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 TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO RETRACT. 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 LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE WITH THE VESSEL AND DAMAGED TIP OF THE GUIDE WIRE DURING USE. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE REPORTED RESISTANCE WITH THE VESSEL AND THE NOTED GUIDE WIRE TIP SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS 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 DURING AN INTERVENTIONAL PROCEDURE OF THE POSTERIOR DESCENDING ARTERY, THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS BEING UTILIZED IN MULTIPLE VESSELS WITHOUT REPORTED INCIDENT DURING AN UNSUCCESSFUL NON-ABBOTT STENTING. DURING REMOVAL OF THE BMW IT BECAME STUCK IN THE VESSEL AND UNRAVELED AT THE TIP. THE DEVICE WAS SUCCESSFULLY REMOVED IN ONE PIECE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. RETURN DEVICE ANALYSIS REVEALED THE SHAPING RIBBON WAS SEPARATED.

    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 1020874

    Patients

    Seq Age Sex Outcome Treatment
    1