BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1964368 · Received January 19, 2011

    Report

    Report Number
    2024168-2011-00382
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    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. DILATATION CATHETER: TAZUNA; GUIDE WIRE: BMW; GUIDE CATH: HAERTRAIL I JR4; STENT: ENDEAVOR RESISTANCE BETWEEN AN IVUS CATHETER AND THE GUIDE WIRE CAN OCCUR DUE TO, BUT NOT LIMITED TO, A DAMAGED GUIDE WIRE, CONDITION OF THE WIRE COATING, PATIENT ANATOMICAL MORPHOLOGY, WIRE MANIPULATION TECHNIQUE, AND/OR LESION CHARACTERISTICS. IN SOME INSTANCES, SUCH AS DURING MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING, AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCE BETWEEN THE WIRE AND THE IVUS CATHETER CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND CAUSE RESISTANCE BETWEEN DEVICES. COAGULATION OF BLOOD OR CONTRAST CAN ALSO BE A FACTOR IN REDUCING CLEARANCE. THE LESION WAS DESCRIBED AS MODERATELY CALCIFIED WITH 99% STENOSIS, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTY AS EXPLAINED ABOVE. IT IS ALSO POSSIBLE THAT THE IVUS CATHETER WAS KINKED/DAMAGED, WHICH ALSO COULD HAVE CONTRIBUTED TO THE DIFFICULTY. REPORTEDLY, THERE WAS A KINK IN THE GUIDE WIRE WHEN IT WAS REMOVED FROM THE IVUS CATHETER WHICH IS CONSISTENT WITH PRODUCT HANDLING DURING THE PROCEDURE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. THE IVUS CATHETER AND THE GUIDE WIRE WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE INVESTIGATION. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE REPORTED RESISTANCE BETWEEN THE IVUS AND THE GUIDE WIRE AND KINK IN THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE, AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN ORDER TO ENSURE THAT DAMAGE TO THE WIRE THAT COULD CAUSE RESISTANCE DOES NOT OCCUR DUE TO A PRODUCT QUALITY DEFICIENCY, MANUFACTURING VISUALLY INSPECTS 100% OF THE GUIDE WIRE TIP AFTER LOADING 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 LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED, WITH A 99% STENOSIS. AFTER THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE LESION, AN INTRAVASCULAR ULTRASOUND (IVUS) WAS ADVANCED. AFTER PERFORMING IVUS, THE MOVEMENT BETWEEN THE IVUS CATHETER AND THE BMW GUIDE WIRE WAS DIMINISHED. THE IVUS CATHETER AND THE BMW GUIDE WIRE WERE REMOVED FROM THE PATIENT TOGETHER. WHEN THE CATHETER WAS SEPARATED FROM THE BMW GUIDE WIRE, OUTSIDE THE PATIENT, THE GUIDE WIRE WAS FOUND TO BE KINKED. NO PATIENT EFFECTS WERE 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 0090871

    Patients

    Seq Age Sex Outcome Treatment
    1