BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 1901777 · Received November 17, 2010

    Report

    Report Number
    2024168-2010-02457
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 20, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED GUIDE WIRE FOUND BLOOD AND CONTRAST ON THE CORE AND COILS. THE CORE WAS SEPARATED 1.2 CM DISTAL TO THE CENTER SOLDER, BUT REMAINED INTACT AT THE TIPBALL. THE TIP COILS WERE INTACT AND NOT SEPARATED, BUT WERE STRETCHED OUT FOR A LENGTH OF 5.5 CM DISTAL TO THE CENTER SOLDER. THE TIP COILS PROXIMAL TO THE TIPBALL WERE NOT STRETCHED FOR A LENGTH OF 2.4 CM PROXIMAL TO THE TIPBALL. ADDITIONALLY, THE GUIDE WIRE WAS SENT FOR SCANNING ELECTRON MICROSCOPY (SEM), WHICH DETERMINED THAT THE CORE FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD AND THAT THE CORE EXHIBITED A TWISTED APPEARANCE WITH SWIRLED DIMPLES ON THE FRACTURE SURFACE. DIFFICULTY POSITIONING THE GUIDE WIRE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMY, INNER/OUTER DIAMETER RELATIONSHIPS, THE CONDITION OF ASSOCIATIVE PRODUCTS, AND/OR CONDITION OF WIRE COATING. A GUIDE WIRE SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION, WHICH WAS SEEN IN THE SEM IMAGES. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE ASSOCIATIVE PRODUCT OR ON THE WIRE CAN ALSO BE A FACTOR IN REDUCING CLEARANCE. IN CERTAIN CIRCUMSTANCES, SUCH AS DURING HIGH PRESSURE BALLOON INFLATIONS, 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. AN ATTEMPT TO MOVE THE WIRE IN THIS REDUCED CLEARANCE CONDITION CAN CAUSE THE COILS TO BUNCH UP, INCREASING THE DIAMETER OF THE GUIDE WIRE, WHICH IN THE EXTREME CONDITION CAN CAUSE COIL OVERLAP. IF THE RESISTANCE IS NOT REDUCED AND CONTINUED FORCE IS APPLIED TO THE SYSTEM, THE RESULT IS PERMANENT DEFORMATION OF THE WIRE AND/OR GUIDE WIRE LUMEN. ANALYSIS ALSO REVEALED CORROSION ON THE PROXIMAL SOLDER, CENTER SOLDER, AND TIPBALL; HOWEVER THIS APPEARS TO BE RELATED TO TRANSPORT BACK TO ABBOTT VASCULAR, AND IS UNRELATED TO THE REPORTED DAMAGE. IN ORDER TO ENSURE THAT GUIDE WIRE DAMAGE THAT COULD POTENTIALLY CONTRIBUTE TO THE REPORTED DIFFICULTIES DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A NON-DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND INDICATES THAT THIS LOT MET ALL MANUFACTURING RELEASE REQUIREMENTS AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO DAMAGE TO THE GUIDE WIRE WAS REPORTED PRIOR TO USE, WHICH WOULD INDICATE THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. OVERALL, BASED ON THE REPORTED INFORMATION A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTIES AND GUIDE WIRE DAMAGE AND THE CORROSION IS LIKELY DUE TO TRANSPORTATION BACK TO ABBOTT VASCULAR FOR EVALUATION, BUT THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A 3.00X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED AT AN UNKNOWN TIME DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA). THE 70% STENOSED, DENOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT CIRCUMFLEX (LCX). THE LESION WAS PREDILATED WITH A 2.00X15MM NON BSC BALLOON AND THEN A 2.25X12MM PROMUS ELEMENT SDS WAS ADVANCED; HOWEVER, WHEN THE SDS REACHED THE AORTIC BRANCH, THE DEVICE WAS UNABLE TO BE ADVANCED FURTHER. AFTER TWO UNSUCCESSFUL ATTEMPTS TO CROSS THE AORTIC BRANCH THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS ENDED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT¿S CONDITION IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT OF THE GUIDE WIRE. UPON REMOVAL, THE TIP WAS NOTED TO BE UNWOUND. THERE WAS NO ADVERSE PATIENT SEQUELA. ANOTHER GUIDE WIRE WAS USED SUCCESSFULLY. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-MURRIETA 0060791

    Patients

    Seq Age Sex Outcome Treatment
    1