BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE ADVANCE GUIDE WIRE

    MDR report key: 2061588 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02715
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 WHICH ARE CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED, 3 CM PROXIMAL TO THE TIP BALL. THE SEPARATED PORTION WAS RETURNED. THE INTERMEDIATE COILS WERE SEPARATED 22 CM DISTAL TO THE PROXIMAL SOLDER. THE SEPARATED INTERMEDIATE COILS WERE RETURNED. THE INTERMEDIATE COILS WERE COMPLETELY STRETCHED OUT. THE STRETCHED AND SEPARATED INTERMEDIATE COILS APPEAR TO BE THE RESULT OF THE REPORTED GUIDE WIRE SEPARATION AND/OR INTERACTION WITH THE LESION ANATOMY. THE INABILITY TO CROSS A LESION AND RESISTANCE WITH THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, THE LESION WAS DESCRIBED AS OCCLUDED WHICH COULD HAVE CONTRIBUTED TO THE INABILITY TO CROSS THE LESION AND RESISTANCE. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THE PROXIMAL HALF OF THE INTERMEDIATE COIL END AND THE INTERMEDIATE COIL END FAILURES MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THE OTHER INTERMEDIATE COIL ENDS FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE AND DUCTILE OVERLOAD. FOR THE WIRE TO FAIL IN THIS MANNER THE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING OR OVER TORQUED BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY AND/OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. IN THIS CASE, THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE THE RESULT OF THE RESISTANCE FELT WHEN REMOVING THE GUIDE WIRE FROM THE LESION ANATOMY. ADDITIONALLY, THE LESION WAS DESCRIBED AS OCCLUDED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. REPORTEDLY, THE SEPARATED GUIDE WIRE WAS RETRIEVED DURING BYPASS SURGERY. TO ENSURE THAT GUIDE WIRE TIP SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE REPORTED GUIDE WIRE SEPARATION, INABILITY TO RETRACT THE GUIDE WIRE AND THE TREATMENTS APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS 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 PATIENT WAS BROUGHT TO THE HOSPITAL WITH TWO ACUTE OCCLUSIONS. ONE OCCLUSION WAS IN THE RIGHT CORONARY ARTERY WHICH WAS TREATED USING THE ADVANCE GUIDE WIRE WITH A GOOD RESULT. THE SECOND OCCLUSION WAS IN THE LEFT CORONARY ARTERY AND THE SAME GUIDE WIRE WAS USED; HOWEVER, THE GUIDE WIRE DID NOT CROSS THE TARGET LESION AND AS THE GUIDE WIRE WAS REMOVED, RESISTANCE WAS FELT AND THE GUIDE WIRE SEPARATED LEAVING THE DISTAL PIECE OF THE GUIDE WIRE IN THE PATIENTS VESSEL. ATTEMPTS TO RETRIEVE THE GUIDE WIRE WERE UNSUCCESSFUL; THEREFORE, THE PATIENT UNDERWENT BYPASS SURGERY. THE SEPARATED TIP WAS REMOVED DURING THE BYPASS SURGERY. THE PATIENT RECOVERED AFTER THE SURGERY AND IS IN STABLE CONDITION NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE ADVANCE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0092791

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S