BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 1953124 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00114
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    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. RESISTANCE BETWEEN AN IVUS CATHETER AND THE GUIDE WIRE CAN OCCUR DUE TO, BUT IS 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. IN THIS CASE, THE LESION WAS DESCRIBED AS MILDLY CALCIFIED AND 75% STENOSED, 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. THE IVUS CATHETER AND THE GUIDE WIRE WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE INVESTIGATION. OVERALL, A CONCLUSIVE CAUSE OF THE REPORTED RESISTANCE BETWEEN THE IVUS AND THE GUIDE WIRE CANNOT BE DETERMINED, AND THERE IS NO INDICATION OF 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 AFTER INTRA-VASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH THE BMW UNIVERSAL II GUIDE WIRE, THE TWO DEVICES BECAME STUCK TO EACH OTHER. THEY WERE WITHDRAWN FROM THE PATIENT AS A UNIT. ANOTHER BMW UNIVERSAL II WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0090471

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR