BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2241060 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06229
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 TREK OTW BALLOON DILATATION CATHETER IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE CORE AND NO CONTRAST VISIBLE WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED, 3.7 CM DISTAL TO THE PROXIMAL SOLDER. THE INTERMEDIATE COILS WERE COMPLETELY STRETCHED OUT AND SEPARATED. THE SEPARATED PORTION INCLUDING THE STRETCHED INTERMEDIATE COILS WERE RETURNED INSIDE THE GUIDE WIRE LUMEN OF THE RETURNED BALLOON CATHETER FOR A LENGTH OF 8.5 CM. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE SHAPING RIBBON EXHIBITED A BENT PROFILE AND NECKING. FAILURE OF THE SHAPING RIBBON MAY BE ATTRIBUTED TO TENSILE OVERLOAD. THE PROXIMAL TIP COIL FRACTURE EXHIBITED NECKING AND TWISTING AND FAILURE MAY BE ATTRIBUTED TO TENSILE OVERLOAD. THE DISTAL TIP COIL FRACTURE EXHIBITED SWIRLED DIMPLES AND FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THE TIP BALL WAS MISSING AND THE CENTER SOLDER APPEARED INTACT. GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. A 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 WIRE AS DESCRIBED. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. THE VESSEL WAS DESCRIBED AS HEAVILY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED SEPARATION. ADDITIONALLY, IT WAS REPORTED THAT RESISTANCE WAS FELT FROM THE CONTRACTING DISTAL VESSEL WHICH COULD ALSO CONTRIBUTED TO THE REPORTED SEPARATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THE INCIDENT, THE INABILITY TO CROSS APPEARS TO BE RELATED TO THE HEAVILY TORTUOUS ANATOMY. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE CROSSING 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. 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 DISTAL END OF THE VESSEL WAS DESCRIBED AS HEAVILY TORTUOUS AND SEEMED TO COLLAPSE WHEN THE HEART CONTRACTED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, PERFORMS A NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS A 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE REPORTED LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATE NO RELATED INCIDENTS. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED RESISTANCE WITH THE LESION, INABILITY TO CROSS THE LESION AND GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MID RIGHT CORONARY ARTERY (MRCA) INTERVENTION TO TREAT AN UNKNOWN BARE METAL RESTENOSED STENT, THE LONG BMW UNIVERSAL GUIDE WIRE FAILED TO ADVANCE TO THE DISTAL END OF THE HEAVILY TORTUOUS RCA; HOWEVER, A CHOICE PT GUIDE WIRE WAS SUCCESSFULLY PLACED. A 3.5X15MM TREK OTW BALLOON WAS SUCCESSFULLY ADVANCED TO THE LESION AND PERFORMED AS INTENDED. THE CHOICE PT GUIDE WIRE WAS REMOVED FROM THE ANATOMY, THE TREK BALLOON REMAINED AND THE LONG BMW UNIVERSAL GUIDE WIRE WAS RE-ADVANCED THROUGH THE TREK BALLOON CATHETER INTO THE DISTAL END OF THE VESSEL WITH SOME RESISTANCE. THE DISTAL END OF THE VESSEL WAS HEAVILY TORTUOUS AND SEEMED TO COLLAPSE WHEN THE HEART CONTRACTED. DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE, RESISTANCE WAS MET FROM THE CONTRACTING DISTAL VESSEL. THE BMW UNIVERSAL GUIDE WIRE AND BALLOON DELIVERY CATHETER WERE REMOVED AS ONE UNIT. UPON REMOVAL OF THE GUIDE WIRE, IT WAS NOTICED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED FROM THE WIRE, BUT REMAINED IN THE BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 1051071

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR DIL CATH: TREK OTW 3.5 X 15 MM