BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 3022099 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01742
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. HOWEVER, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED 20-28 MM IN LENGTH BARE METAL STENT IMPLANTED IN THE PROXIMAL-MID RIGHT CORONARY ARTERY (RCA) AT AN UNSPECIFIED TIME WAS RESTENOSED. WITH A FEMORAL ARTERY ACCESS, A BALANCED MIDDLEWEIGHT (BMW) GUIDE WIRE WITH A NON-ABBOT SUPPORT CATHETER WAS ADVANCED INTO THE TOTALLY OCCLUDED PROXIMAL RCA THROUGH THE UNSPECIFIED BARE METAL STENT STRUTS AND MET RESISTANCE WITH THE UNSPECIFIED STENT STRUTS CAUSING THE BMW GUIDE WIRE TO ENTER THE SUBINTIMAL SPACE OF THE PATIENT. THERE WAS A FLUOROSCOPY DONE WITH DYE AND IT WAS DECIDED TO ABANDON THE PROCEDURE. THE BMW AND THE NON-ABBOT SUPPORT CATHETER WERE REMOVED AND UPON REMOVAL THE BMW GUIDE WIRE WAS FOUND SEPARATED PROXIMAL TO THE MARKER BAND. THE DISTAL PART OF THE BMW GUIDE WIRE WAS FOUND STILL IN THE SUBINTIMAL SPACE, NOT IN THE PATIENTS VASCULAR SYSTEM; THEREFORE, IT WAS DECIDED TO LEAVE THE SEPARATED PORTION OF THE GUIDE WIRE INSIDE THE PATIENTS ANATOMY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123497 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2112871

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other OTHER: CROSS BOSSSTENT: UNSPECIFIED BARE METAL