BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2113427 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03870
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD VISIBLE AND CONTRAST IN THE COILS. 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 STILL INTACT. THERE WERE OFFSET INTERMEDIATE COILS SPORADICALLY 1 MM PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 4.5 CM. THERE WERE OVERLAPPING INTERMEDIATE COILS, 8.2 CM DISTAL TO THE PROXIMAL SOLDER FOR A LENGTH OF 1 MM. THE TIP COILS WERE STRETCHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 2 MM. THESE NOTED OFFSET, OVERLAPPING AND STRETCHED COILS ARE CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS COULD NOT CONFIRM THE REPORTED RESISTANCE WHILE POSITIONING THE OTHER DEVICE AS THE RETURNED GUIDE WIRE WAS USED IN AN ATTEMPT TO BACK LOAD THROUGH A NEW BALLOON CATHETER, BUT THE GUIDE WIRE WOULD NOT ADVANCE PAST THE NOTED OVERLAPPING INTERMEDIATE COILS. ANALYSIS CONFIRMED THE DIFFICULTY RETRACTING THE GUIDE WIRE FROM THE OTHER DEVICE DUE TO THE NOTED OVERLAPPING INTERMEDIATE COILS. THE OUTER DIAMETER OF THE SOLDER JOINTS WERE MEASURED WITH A HOLE GAUGE; HOWEVER, THE HOLE GAUGE WOULD NOT ADVANCE PAST THE OVERLAPPING INTERMEDIATE COILS. THIS DID NOT MEET MANUFACTURING CRITERIA. THE OUTER DIAMETER OF THE GUIDE WIRE PROXIMAL TO THE HYPOTUBE WAS MEASURED WITH A LASER MICROMETER AND MET MANUFACTURING CRITERIA. 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 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. 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 TIP AFTER IT IS LOADED INTO THE DISPENSER 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. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE 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. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE RESISTANCE DURING ADVANCEMENT AND THE REPORTED RESISTANCE RETRACTING APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POST-DILATION WITH A VOYAGER NC RESISTANCE WAS ENCOUNTERED WITH THE BMW GUIDE WIRE DURING ADVANCEMENT. THE VOYAGER NC BECAME STUCK ON THE BMW GUIDE WIRE. RESISTANCE WAS ALSO EXPERIENCED DURING RETRACTION OF THE BALLOON, AND THE GUIDE WIRE WITH THE BALLOON LOST POSITIONING IN THE LESION AND WERE REMOVED FROM THE ANATOMY AS A UNIT. THE PHYSICIAN FELT THAT THE RESULTS OF THE ANGIOPLASTY WERE OPTIMAL, AND DECIDED NOT TO PERFORM POST-DILATATION. THE PHYSICIAN INSPECTED THE GUIDE WIRE AND FELT A THICKENED AREA. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PROCEDURE WAS NOT PROLONGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0121771

    Patients

    Seq Age Sex Outcome Treatment
    1 VOYAGER NC