BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 2801016 · Received October 18, 2012

    Report

    Report Number
    3006010712-2012-00008
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS TO WHY THE EVENT OCCURRED AS THE GUIDEWIRE INVOLVED IN THE INCIDENT WAS NOT RETURNED AND ANALYSIS WAS NOT POSSIBLE. THE LOT NUMBER REMAINS TO BE UNKNOWN DESPITE EFFORTS TO OBTAIN THE LOT NUMBER FROM THE CUSTOMER. ANALYSIS AND CONCLUSION: THE GUIDEWIRE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR INVESTIGATION. THE LOT NUMBER REMAINS TO BE UNKNOWN DESPITE EFFORTS TO OBTAIN THE LOT NUMBER FROM THE CUSTOMER. NO FLUOROSCOPY IMAGES WERE PROVIDED FOR REVIEW. THESE ISSUES MAY IT DIFFICULT IF NOT IMPOSSIBLE TO ASCERTAIN THE SOURCE OF THE COMPLAINT. IT IS DIFFICULT TO DRAW ANY CONCLUSION BASED ON THE SINGLE IMAGE OF THE GUIDEWIRE INVOLVED IN THE COMPLAINT, AS PROVIDED BY THE CUSTOMER. IT IS LIKELY THAT THE GUIDEWIRE GOT SNAGGED AT THE TIP AND BECAME CURLED UPON ATTEMPTS TO FREE THE DEVICE; HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE EVIDENCE PROVIDED. THE PROCEDURE AS DESCRIBED IN THE INCIDENT REPORT INVOLVED PLACING THE WIRE THROUGH THE STENT STRUT. USE OF THIS TECHNIQUE INVOLVES ADDITIONAL PT RISKS, INCLUDING THE RISK THAT THE WIRE MAY BECOME CAUGHT ON THE STENT STRUT. THIS IS OUTLINED IN THE PRODUCT DIRECTIONS FOR USE. THE INITIAL COMPLAINT REPORT STATED THAT THERE WAS A SIGNIFICANT IMPACT TO THE PT DUE TO A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON (B)(6), REGARDING PT STATUS: "PT HAD A DEGREE OF RENAL FAILURE. POST OP FOLLOWING FEM POP BYPASS PT WAS IN SEVERE RENAL FAILURE-NOT PASSING URINE". IT CANNOT BE CONFIRMED HOWEVER, IF THE DELAY IN PROCEDURE RESULTED IN THE OCCURRENCE OF RENAL FAILURE IN THE PT OR IF THE RENAL FAILURE WAS AS A RESULT OF AN EXISTING CONDITION OR OTHER CONTRIBUTING FACTOR. POST MARKET PERFORMANCE OF THE GUIDEWIRE DEVICE DOES NOT INDICATE ANY CONCERNING TRENDS FOR THIS TYPE OF DEFECT. LAKE REGION WILL CONTINUE TO MONITOR POST MARKET EXPERIENCE FOR ANY SIMILAR TRENDS.

    Description of Event or Problem · 1

    AN INCIDENT REPORT WAS RECEIVED FROM OUR CUSTOMER DETAILING THE FOLLOWING: "IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE ABSOLUTE PRO STENT WAS IMPLANTED, THE CONNECT GUIDE WIRE WAS ATTEMPTED TO BE REMOVED, BUT WAS STUCK ON THE DISTAL END OF THE IMPLANTED STENT. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE WITH THE USE OF THE GUIDING CATHETER, BUT WERE UNSUCCESSFUL. THE PT WAS SENT TO SURGERY FOR REMOVAL OF THE GUIDE WIRE AND A POPLITEAL BYPASS GRAFT. THE CONNECT GUIDE WIRE WAS CUT AND LEFT IN THE PORTION OF THE SFA THAT WAS BYPASSED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PT WAS SENT TO SURGERY FOR REMOVAL OF THE GUIDE WIRE AND A POPLITEAL BYPASS GRAFT. THE CONNECT GUIDE WIRE WAS CUT AND LEFT IN THE PORTION OF THE SFA THAT WAS BYPASSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-03 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O