BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 2113577 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03872
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 NO BLOOD VISIBLE AND CONTRAST ON THE BLACK POLYMER COATING. IT IS POSSIBLE THAT THE GUIDE WIRE WAS WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. ANALYSIS DID NOT CONFIRM THE REPORTED PEELING OF THE POLYMER COATING AS THERE WAS NO PEELING NOTED TO THE GUIDE WIRE. ANALYSIS ALSO NOTED TIP SEPARATION, 28.3 CM DISTAL TO THE PROXIMAL END OF THE BLACK POLYMER COATING. THE MATERIAL AT THE SEPARATION WAS JAGGED. THE SEPARATED PORTION WAS NOT RETURNED. THERE WAS CORE EXPOSED IN LENGTH OF 8 MM DISTAL TO THE SEPARATION. THERE WAS A BEND IN THE CORE, 1.3 CM PROXIMAL TO THE SEPARATION. GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS 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 GUIDE WIRE WAS USED TO TREAT A TOTALLY OCCLUDED LESION WHICH COULD HAVE CONTRIBUTED TO THE REPORTED SEPARATION. ADDITIONALLY, SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD. THE PROXIMAL HALF OF THE CORE EXHIBITED SLIGHT NECKING AND DIMPLES. FAILURE OF THE CORE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. SINCE NO DAMAGE WAS NOTED DURING INSPECTION PRIOR TO THE PROCEDURE, THE NOTED BEND NEAR THE SEPARATION LIKELY OCCURRED WHILE ADVANCING DURING THE PROCEDURE, CAUSING THE WIRE TO BE MORE VULNERABLE TO SEPARATION ONCE FORCE WAS APPLIED. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PEELING OF THE POLYMER COATING AND THE REPORTED GUIDE WIRE SEPARATION 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PILOT GUIDE WIRE WAS USED TO CROSS A CHRONICALLY TOTALLY OCCLUDED (CTO) LESION WITH CALCIFICATION. ABOUT 1 CENTIMETER LENGTH OF THE COATING OF THE GUIDE WIRE TIP WAS NOTED TO BE PEELING, BUT NOT SEPARATED FROM THE GUIDE WIRE DURING USE. DURING THE PROCESS OF PREPARATION FOR RETURN OF THE PRODUCT, THE COATING SEPARATED FROM THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0052791

    Patients

    Seq Age Sex Outcome Treatment
    1