BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 6382675 · Received March 6, 2017

    Report

    Report Number
    2024168-2017-01865
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    February 22, 2017
    Report Date
    March 6, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE UNIQUE DEVICE IDENTIFIER (UDI) IS REPORTED AS UNKNOWN BECAUSE IT COULD NOT BE CONFIRMED WHICH OF TWO WIRES SEPARATED; THEREFORE, THE UDI AND LOT HISTORY RECORD REVIEW ARE PROVIDED FOR BOTH WIRES AS FOLLOWS: CATALOG / LOT #: 1005357H / 5080371. MANUFACTURING DATE: 08/31/2015. EXPIRATION DATE: (B)(6) 2017. CATALOG / LOT #: 1005357H / 5093071. MANUFACTURING DATE: 09/30/2015. EXPIRATION DATE: (B)(6) 2017. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE HI TORQUE GUIDE WIRE INSTRUCTIONS FOR USE STATES: DO CONSIDER THAT IF A SECONDARY WIRE IS PLACED IN A BIFURCATION BRANCH, THIS WIRE MAY NEED TO BE RETRACTED PRIOR TO STENT DEPLOYMENT BECAUSE THERE IS ADDITIONAL RISK THAT THE SECONDARY WIRE MAY BECOME ENTRAPPED BETWEEN THE VESSEL WALL AND THE STENT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES TO BE RELATED TO USER TECHNIQUE AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A BIFURCATION LESION. ONE WHISPER GUIDE WIRE WAS PLACED IN ONE VESSEL AND A SECOND WHISPER GUIDE WIRE WAS PLACED IN THE SECOND VESSEL. AN UNSPECIFIED STENT WAS DEPLOYED, TRAPPING THE GUIDE WIRE BEHIND THE DEPLOYED STENT. THE GUIDE WIRE SEPARATED. THERE WAS NO ATTEMPT MADE TO REMOVE THE SEPARATED GUIDE WIRE SEGMENT, WHICH REMAINS TRAPPED BEHIND THE IMPLANTED STENT. POST PROCEDURE, THE PATIENT REMAINED IN STABLE CONDITION AND WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162696 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other