BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2212220 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05749
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THE COMPLAINT, THE INABILITY TO CROSS APPEARS TO BE RELATED TO THE HEAVILY CALCIFIED LESION. 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 AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. REPORTEDLY, WHEN THE GUIDE WIRE WAS ADVANCED AND UNABLE TO CROSS THE LESION, A DISSECTION WAS OBSERVED IN THE MID RIGHT CORONARY ARTERY. IT IS UNKNOWN WHETHER THE ATTEMPTS MADE TO ADVANCE THE GUIDE WIRES TO THE LESION CONTRIBUTED TO THE REPORTED DISSECTION AND IT SHOULD BE NOTED IN THE WHISPER GUIDE WIRE INSTRUCTIONS FOR USE (IFU) WARNINGS SECTION: DO: 1) ADVANCE OR WITHDRAW THE GUIDE WIRE SLOWLY. 2) USE THE RADIOPAQUE MARKER OF THE INTERVENTIONAL DEVICE TO CONFIRM POSITION. 3) EXAMINE THE TIP MOVEMENT UNDER FLUOROSCOPY BEFORE MANIPULATING, MOVING, OR TORQUING THE GUIDE WIRE. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. REPORTEDLY, THE DISSECTION WAS NOT TREATED AND THE PATIENT WAS ADVISED TO UNDERGO SURGERY DUE TO THE INABILITY TO TREAT THE LESION WITH STENTING. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NONCONFORMANCES FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE REVEALED NO RELATED INCIDENTS. IN SUMMARY, BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. AN ATTEMPT WAS MADE TO ADVANCE THE BMW UNIVERSAL GUIDE WIRE, BUT THE GUIDE WIRE WAS UNABLE TO CROSS THE LESION. THE WHISPER GUIDE WIRE WAS THEN ADVANCED; HOWEVER, THIS GUIDE WIRE WAS ALSO UNABLE TO CROSS THE LESION, AND A DISSECTION WAS OBSERVED IN THE MID RCA. THE DISSECTION WAS NOT TREATED AND THE PATIENT WAS ADVISED TO UNDERGO SURGERY DUE TO THE INABILITY TO TREAT THE LESION WITH STENTING. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 1021501

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention GUIDE WIRE: BMW UNIVERSAL