BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2072257 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02982
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. GUIDE WIRE: BMW. GUIDE CATHETER: XB 3.5. SHEATH: CORDIS. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD OR CONTRAST VISIBLE. IT IS POSSIBLE THAT THE GUIDE WIRE WAS WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS ALSO NOTED OFFSET AND OVERLAPPED INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 5 MM. THE TIP COILS WERE STRETCHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 1 MM. THESE NOTED DAMAGES ARE CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE DURING THE PROCEDURE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS ALSO NOTED THAT THE CATHETER USED IN THE PROCEDURE WAS NOT RETURNED. ANALYSIS CONFIRMED THE REPORTED INABILITY TO ADVANCE AND RETRACT THE SDS OVER THE GUIDE WIRE AS A NEW CATHETER WAS USED TO ADVANCE OVER THE RETURNED GUIDE WIRE AND THERE WAS RESISTANCE FELT AT THE DAMAGED COILS NOTED. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED WITH A HOLE GAUGE AND DID NOT MET MANUFACTURING CRITERIA. THE TIP OF THE GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE UNTIL PROXIMAL TO THE CENTER SOLDER. THE HOLE GAUGE WOULD NOT ADVANCE PAST THE OFFSET AND OVERLAPPED INTERMEDIATE COILS. AN ATTEMPT WAS MADE TO BACK LOAD THE RETURNED GUIDE WIRE THROUGH A NEW CATHETER, BUT THE GUIDE WIRE WOULD NOT ADVANCE PAST THE NOTED OFFSET AND OVERLAPPED INTERMEDIATE COLS. DIFFICULTY TO ADVANCE AND RETRACT THE SDS OVER THE GUIDE WIRE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMY, INNER/OUTER DIAMETER RELATIONSHIPS, THE CONDITION OF THE ASSOCIATIVE PRODUCT, AND/OR CONDITION OF GUIDE WIRE COATING. THE DESIGN OF LOW PROFILE PRODUCTS HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. 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. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER CAN ALSO BE A FACTOR IN REDUCING CLEARANCE. AN ATTEMPT TO MOVE THE GUIDE WIRE IN THIS REDUCED CLEARANCE CAN CAUSE THE COILS TO BUNCH UP, WHICH CAN INCREASE THE DIAMETER OF THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN DEVICES AND CAN CAUSE THE COILS TO OFFSET AND/OR OVERLAP. IF THE RESISTANCE IS NOT REDUCED AND CONTINUED FORCE IS APPLIED TO THE GUIDE WIRE WITH AN OFFSET COIL, THE RESULT IS PERMANENT DEFORMATION OF THE GUIDE WIRE WHICH COULD CAUSE RESISTANCE OR POSITIONING DIFFICULTIES WITH THE CATHETER. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE 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. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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 DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. DURING ADVANCEMENT OF A NON-ABBOTT STENT DELIVERY SYSTEM (SDS) OVER THE BMW GUIDE WIRE, THE SDS STUCK WITH THE GUIDE WIRE AND COULD NOT BE ADVANCED; THEREFORE, BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE NON-ABBOTT SDS WAS REMOVED FROM THE GUIDE WIRE, AND SUCCESSFULLY PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0031272

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR