BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2072932 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03006
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST ON THE COILS AND CORE WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THERE WAS A BEND IN THE TIP, 5 MM PROXIMAL TO THE TIP BALL WHICH IS CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY DURING PROCEDURAL ATTEMPTS TO CROSS THE LESION AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. THE IVUS CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. ANALYSIS COULD NOT CONFIRM THE REPORTED RESISTANCE AS THE RETURNED GUIDE WIRE WAS BACKLOADED THROUGH A NEW BALLOON CATHETER WITHOUT RESISTANCE NOTED. THE OUTER DIAMETER OF THE SOLDER JOINTS WERE MEASURED WITH A HOLE GAUGE AND MET MANUFACTURING CRITERIA. THE OUTER DIAMETER OF THE GUIDE WIRE PROXIMAL TO THE HYPOTUBE WAS MEASURED WITH A LASER MICROMETER AND MET MANUFACTURING CRITERIA. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE CROSSING OR WHILE IN THE LESION AND WITH OTHER DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY, LESION MORPHOLOGY, DEVICE SELECTION, DEVICE PLACEMENT TECHNIQUE, AND/OR INTERACTION BETWEEN ASSOCIATED DEVICES. OTHER FACTORS MAY ALSO CONSIST OF ANATOMICAL CONDITIONS, SUCH AS TORTUOUS VESSELS, AS THEY COULD CAUSE THE SHAPE OF THE GUIDE WIRE OR IVUS TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO ADVANCE THE IVUS OVER THE WIRE. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE IVUS. IN CERTAIN CIRCUMSTANCES, SUCH AS MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. THE LESION WAS DESCRIBED AS 99% STENOSED WITH MODERATE CALCIFICATION AND THE VESSEL WAS MODERATELY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES AS EXPLAINED ABOVE. THE LOT HISTORY RECORD WAS REVIEWED. 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. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE BMW GUIDE WIRE WAS ADVANCED; HOWEVER, THE DEVICE DID NOT CROSS THE LESION. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE GUIDE WIRE WITH A MICRO-CATHETER, AND THIS ATTEMPT WAS SUCCESSFUL. DURING ADVANCEMENT OF THE INTRA-VASCULAR ULTRASOUND (IVUS), IT BECAME STUCK WITH THE BMW GUIDE WIRE, AND BOTH DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE BMW GUIDE WIRE WAS REMOVED FROM THE IVUS, AND ANOTHER ATTEMPT WAS MADE TO DELIVER THE IVUS; HOWEVER, DUE TO THE LESION, THE DEVICE WOULD NOT CROSS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 1012471

    Patients

    Seq Age Sex Outcome Treatment
    1 IVUS