BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2193245 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05552
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DIL CATH: TAZUNA 2.0X15. GUIDE CATH: AXESS 6F FL3.5. RESISTANCE BETWEEN DEVICES CAN OCCUR TO NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, INTERACTION WITH OTHER DEVICES, LESION MORPHOLOGY, PATIENT ANATOMY/DISEASE STATE, THE CONDITION OF THE CATHETER BEING USED, AND/OR CONDITION OF THE WIRE COATING. 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 COULD LEAD TO RESISTANCE. IN THIS CASE, THE LESION WAS DESCRIBED WITH 99% STENOSIS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE GUIDE WIRE AND THE BALLOON CATHETER WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. 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 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. OVERALL, THE REPORTED RESISTANCE APPEARS 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 PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE DISTAL CIRCUMFLEX WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE BMW GUIDE WIRE WAS ADVANCED TO THE LESION, AND PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. DURING REMOVAL OF THE BALLOON CATHETER, RESISTANCE WAS MET WITH THE GUIDE WIRE; THEREFORE, BOTH DEVICES WERE REMOVED AND A NEW NON-ABBOTT GUIDE WIRE AND BALLOON CATHETER WERE USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 0052471

    Patients

    Seq Age Sex Outcome Treatment
    1