BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE CONNECT GUIDE WIRE

    MDR report key: 7051373 · Received November 21, 2017

    Report

    Report Number
    2024168-2017-09136
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 31, 2017
    Report Date
    January 19, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI#: IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE ANALYSIS WAS PERFORMED BY LAKE REGION MEDICAL LTD.: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THE DEVICE LOT NUMBER WAS NOT PROVIDED FOR THE LOT HISTORY RECORD REVIEW. THE HI-TORQUE CONNECT DIRECTIONS FOR USE (DFU) WARNS THAT THE GUIDE WIRE IS A DELICATE INSTRUMENT AND MUST NOT BE ADVANCED, WITHDRAWN, OR TORQUED IF RESISTANCE IS MET. THE GUIDE WIRE MUST BE ADVANCED OR WITHDRAWN SLOWLY. GUIDE WIRE MANIPULATION MUST ALWAYS BE OBSERVED UNDER FLUOROSCOPY AND MUST BE OBSERVED FOR TIP BUCKLING, WHICH IS A SIGN OF RESISTANCE. THE DFU ALSO WARNS NOT TO ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. IF THE GUIDE WIRE IS REMOVED AND IS TO BE RE-INSERTED MUST BE INSPECTED FOR SIGNS OF DAMAGE (WEAKENED OR KINKED SEGMENTS) PRIOR TO RE-INTRODUCTION. IT IS NOT ALLOWED TO RE-INTRODUCE IF THE GUIDE WIRE IS WEAKENED OR KINKED. BASED ON THE INFORMATION PROVIDED ABOVE THE MOST LIKELY ROOT CAUSE OF THIS INCIDENT REMAINS THE LESION ANATOMY IN COMBINATION WITH ROBUST HANDLING. IT HAS BEEN DETERMINED THAT THIS EVENT WAS PREVIOUSLY FILED UNDER MFR#3006010712-2017-00028.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN DISTAL SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL. THERE WAS MODERATE TO HEAVY CALCIFICATION PRESENT IN THE VESSEL. DURING ADVANCEMENT OF THE HI TORQUE CONNECT 250T GUIDE WIRE WITH RESISTANCE FELT DUE TO THE CALCIFICATION AND CTO LESION, THE GUIDE WIRE SEPARATED IN THE PATIENT. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017 TO REMOVE THE SEPARATED PIECE OF GUIDE WIRE. THE PATIENT IS REPORTED TO BE DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, NEW INFORMATION RECEIVED IS AS FOLLOWS: THE CHRONIC TOTAL OCCLUSION WAS IN-STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL AND THE POPLITEAL ARTERIES. DURING ATTEMPTED CROSSING OF THE OCCLUDED STENT, IT IS BELIEVED THE GUIDE WIRE DEVELOPED A KNUCKLE/KNOT IN IT LOCKING IT POSSIBLY THROUGH A STENT STRUT. THE PATIENT WAS TRANSFERRED TO PINNACLE HOSPITAL IN HARRISBURG, PENNSYLVANIA FOR SURGICAL REMOVAL OF THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829520 HI-TORQUE CONNECT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R