BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2132492 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04288
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 3.0 X 15 DILATATION CATHETER IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD ON THE COILS AND NO CONTRAST VISIBLE WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THERE WAS CONTRAST VISIBLE IN THE NON-ABBOTT BALLOON. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS CONFIRMED THE REPORTED DIFFICULTY AS THE GUIDE WIRE COULD NOT BE REMOVED FROM THE NON-ABBOTT BALLOON CATHETER. AFTER THE GUIDE WIRE AND NON-ABBOTT BALLOON CATHETER WERE SOAKED IN THE WATER BATH, THE GUIDE WIRE WAS NOT ABLE TO BE REMOVED FROM THE NON-ABBOTT BALLOON CATHETER. ANALYSIS ALSO NOTED THAT THE CORE SEPARATED, 8.1 CM PROXIMAL TO THE END OF THE HYPOTUBE. THE PROXIMAL PORTION OF THE SEPARATION WAS NOT RETURNED. THERE WAS A BEND IN THE CORE, .5 MM DISTAL TO THE SEPARATION. THE TIP WAS BENT IN A HOOK SHAPE. THERE WERE OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 2.5 MM. THE NOTED BEND IN THE CORE AND TIP AND OFFSET INTERMEDIATE COILS ARE LIKELY THE RESULT OF THE NOTED GUIDE WIRE SEPARATION AND/OR MANIPULATION DURING THE PROCEDURE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. A SEPARATED PORTION OF THE NON-ABBOTT BALLOON CATHETER WAS RETURNED FROZEN ON THE GUIDE WIRE. THERE WAS 2.5 CM OF THE GUIDE WIRE EXTENDING OUT FROM THE TIP OF THE NON-ABBOTT BALLOON CATHETER. THE NON-ABBOTT BALLOON CATHETER WAS SEPARATED, 25.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THE PROXIMAL PORTION OF THE SEPARATION WAS NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED. THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE AND TEARING AT A BEND. THE SEPARATED END AND OUTER SURFACE AT THE BEND EXHIBITED MECHANICAL DAMAGE. ELONGATED DIMPLES WERE ALSO OBSERVED ON THE SEPARATED END (BEYOND THE MECHANICALLY DAMAGES REGION) SUGGESTING SHEAR LOADS. RESISTANCE BETWEEN DEVICES CAN OCCUR DUE TO NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, INTERACTION WITH OTHER DEVICES, INSERTION/REMOVAL/PREPARATION TECHNIQUE, LESION MORPHOLOGY, PATIENT ANATOMY/DISEASE STATE, THE CONDITION OF THE CATHETER BEING USED, AND/OR CONDITION OF WIRE COATING. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER OR ON THE WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. AN ATTEMPT TO MOVE THE WIRE IN THIS REDUCED CLEARANCE CAN CAUSE THE COILS TO BUNCH UP OR OVERLAP WHICH CAN INCREASE THE DIAMETER OF THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN DEVICES. IF THIS RESISTANCE IS NOT REDUCED AND CONTINUED FORCE IS APPLIED TO A WIRE WITH OVERLAPPED COILS, THIS CAN RESULT IN PERMANENT DEFORMATION OF THE WIRE AND POSSIBLY LEAD TO THE WIRE BECOMING LOCKED OR FROZEN IN THE CATHETER. ADDITIONALLY, IN CERTAIN CIRCUMSTANCES, SUCH AS DURING HIGH PRESSURE BALLOON INFLATIONS, MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCE BETWEEN DEVICES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND CAUSE THE COILS TO OVERLAP. ADDITIONALLY, THE NOTED GUIDE WIRE SEPARATION APPEARS TO BE THE RESULT OF THE REPORTED RESISTANCE. 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, PERFORMS NON-DESTRUCTIVE PULL TEST AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED RESISTANCE AND THE NOTED GUIDE WIRE SEPARATION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON CATHETER WAS BEING USED WITH A BALANCE MIDDLEWEIGHT GUIDE WIRE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE TREK BALLOON WAS INFLATED ONE TIME AT 14 ATMOSPHERES FOR 20 SECONDS. AFTER BALLOON DEFLATION, DURING REMOVAL OF THE TREK BALLOON CATHETER, RESISTANCE WAS MET WITH THE GUIDE WIRE. THE BALLOON CATHETER AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT AND IT WAS NOTED THAT THE GUIDE WIRE TIP WAS DAMAGED BETWEEN THE SOFT AND RIGID SECTION. A NEW BALLOON CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO ISSUE WITH THE TREK BALLOON CATHETER, AND THE RESISTANCE REPORTED WAS WITH A NON-ABBOTT BALLOON.

    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 1020171

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: TREK 3.0 X 15