BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2070039 · Received April 26, 2011

    Report

    Report Number
    2024168-2011-02951
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 TIP COILS AND THERE WAS TISSUE ON THE TIP COILS AND SHAPING RIBBON WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ADDITIONALLY, THE TIP BALL CORRODED AWAY AND WAS NOT PRESENT, WHICH APPEARS TO BE DUE TO TRANSPORTATION BACK TO ABBOTT VASCULAR FOR EVALUATION, AS IT WAS NOT REPORTED DURING PREPARATION PRIOR TO USE. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE SHAPING RIBBON WAS SEPARATED, 6 MM PROXIMAL TO THE DISTAL END OF THE TIP. THE SEPARATED PORTION INCLUDING THE CORE WAS NOT RETURNED. THE TIP COILS WERE COMPLETELY STRETCHED OUT. THERE WAS A BEND IN THE SHAPING RIBBON, 1 MM AND KINK, 2 MM DISTAL TO THE SHAPING RIBBON SEPARATION WHICH APPEAR TO BE THE RESULT OF THE REPORTED GUIDE WIRE SEPARATION AS THERE WAS NO DAMAGE REPORTED DURING INSPECTION PRIOR TO USE. SCANNING ELECTRON MICROSCOPE ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE SHAPING RIBBON SEPARATION MAY BE ATTRIBUTED TO TENSILE 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 OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. IN THIS CASE, THE LESION WAS DESCRIBED AS TOTALLY OCCLUDED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED TIP SEPARATION. 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 OTHER INCIDENTS REPORTED FOR GUIDE WIRE SEPARATION FOR THIS LOT. 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. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. 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 BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A TOTALLY OCCLUDED LESION IN THE RIGHT CORONARY ARTERY. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR REMOVAL OF THE GUIDE WIRE. DURING HEMOSTASIS, A METALLIC THREAD WAS OBSERVED AT THE PUNCTURE SITE; THEREFORE, THE PHYSICIAN PULLED THE THREAD OUT BY HAND. IT WAS NOTED THAT THE METALLIC THREAD MAY BE THE TIP COIL OF THE BMW GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED REPORTED THAT FIVE DAYS AFTER THE PROCEDURE, ON (B)(6) 2011, A METALLIC THREAD WAS OBSERVED AT THE PUNCTURE SITE; THEREFORE, THE PHYSICIAN PULLED THE THREAD OUT BY HAND.

    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 0112471

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention GUIDE CATH: BRITE TIP 6FFINECROSS MICRO CATHETER