BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

    MDR report key: 2121697 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04137
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INABILITY TO CROSS A LESION CAN BE INFLUENCED BY PHYSICIAN TECHNIQUE, PATIENT ANATOMICAL MORPHOLOGY, AND PATIENT DISEASE STATE. HAVING THE APPROPRIATE EQUIPMENT SELECTED FOR USE, RELATED TO THE CASE CONDITIONS, CAN ALSO SIGNIFICANTLY AFFECT CROSSING AND IT IS EXPECTED THAT WIRES WITH DIFFERENT PERFORMANCE PROPERTIES WOULD PERFORM DIFFERENTLY IN CROSSING ATTEMPTS. THE WIRE CAN ALSO BE DAMAGED IN THE ATTEMPT TO CROSS. IN THIS CASE, THE LESION WAS DESCRIBED AS TOTALLY OCCLUDED, WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTY. THE REPORTED GUIDE WIRE BEING CURLED DURING THE PROCEDURE WAS LIKELY THE RESULT OF THE REPORTED DIFFICULTY CROSSING THE LESION. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE WHILE CROSSING OR WHILE IN THE LESION MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY, LESION MORPHOLOGY, DEVICE SELECTION, AND/OR DEVICE PLACEMENT TECHNIQUE. 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. GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND THE DESIGN LIMITS CAUSING THE DISTAL TIP TO STRETCH AND/OR DETACH. A WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. IN THIS CASE, THE REPORTED SEPARATION WAS LIKELY THE RESULT OF THE REPORTED RESISTANCE. 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, PERFORMS NON-DESTRUCTIVE TIP PULL TEST 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 REPORTED EVENT AND TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR TREATMENT OF A TOTAL OCCLUSION, IN AN UNSPECIFIED VESSEL IN THE LOWER EXTREMITY, A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS ADVANCED, BUT COULD NOT CROSS THE LESION AND THE GUIDE WIRE CURLED. AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE USING THE NORMAL AMOUNT OF FORCE; HOWEVER, THE GUIDE WIRE BECAME STUCK AND SEPARATED. THE DISTAL SEGMENT OF THE GUIDE WIRE REMAINED IN THE GUIDE CATHETER AND WAS RETRIEVED. A NEW 0.14 GUIDE WIRE WAS INSERTED AND PERCUTANEOUS CORONARY ANGIOPLASTY WAS PERFORMED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI GUIDE WIRE DQX AV-TEMECULA-CT 1021771

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention