BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2221666 · Received August 24, 2011

    Report

    Report Number
    2024168-2011-05929
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 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 THE WIRE COATING. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER OR ON THE WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. 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 COULD LEAD TO RESISTANCE. IN THIS CASE, THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. THE GUIDE WIRE WAS NOT RETURNED WHICH COULD 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 FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND LOT NUMBERS WERE NOT REPORTED. THE RX ZETA 2.75 X 23 MM STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED, AND THE 2.75 X 23 MM ZETA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE BMW UNIVERSAL II GUIDE WIRE, AND THE DEVICES STUCK. AN ATTEMPT WAS MADE TO REMOVE THE SDS, BUT RESISTANCE WAS MET WITH THE GUIDE WIRE. DURING THE REMOVAL ATTEMPT, THE STENT BECAME DAMAGED, AND DISLODGED FROM THE SDS BALLOON. THE SDS AND GUIDE WIRE WERE REMOVED AS A UNIT WITH THE DISLODGED STENT. A 2.75 X 28 MM ZETA, AND A NEW GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR STENT: RX ZETA 2.75 X 23 MM