BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE CONNECT GUIDE WIRE

    MDR report key: 11866712 · Received May 21, 2021

    Report

    Report Number
    2024168-2021-04331
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 4, 2021
    Report Date
    August 25, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648175022
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: MEDICAL DEVICE PROBLEM CODE: 2017/AGAINST RESISTANCE. THE ANALYSIS WAS PERFORMED BY LAKE REGION MEDICAL LTD. THE DEVICE LOT HISTORY RECORDS REVIEW HAS SHOWN THAT THERE WERE NO ANOMALIES OR NON-CONFORMANCES RAISED THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), A GUIDEWIRE IS A DELICATE INSTRUMENT AND MUST NOT BE ADVANCED, WITHDRAWN OR TORQUED IF RESISTANCE IS MET. THE IFU WARNS NOT TO WITHDRAW OR TORQUE A GUIDEWIRE THAT MEETS EXCESSIVE RESISTANCE, TORQUE A GUIDEWIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE AND ALLOW THE GUIDEWIRE TIP TO REMAIN IN A PROLAPSED CONDITION. THE TENSILE AND TORQUE TESTS OF THE FINISHED DEVICE WERE PERFORMED ACCORDING TO THE SPECIFICATION AND PASSED. THE OTHER REQUIRED TESTS AND INSPECTIONS WERE PERFORMED AND PASSED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DESIGN OF THE GUIDEWIRE OR ANY MANUFACTURING RELATED CONCERNS HAVE CONTRIBUTED TO THE INCIDENT. IT IS THEREFORE LIKELY THAT THE GUIDEWIRE FRACTURED AFTER BEING CHALLENGED BEYOND ITS DESIGN CAPABILITIES DURING THE PROCEDURE. THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONFIRMED THAT THE FRACTURE OCCURRED DUE TO EXCESSIVE EXTERNAL OVERLOADING. BASED ON THE SEM ANALYSIS AND THE LOT HISTORY RECORDS REVIEW, IT CAN BE CONCLUDED THAT THE CAUSE OF THE FAILURE CANNOT BE TRACED TO THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE LESION WAS HEAVILY CALCIFIED. THE CONNECT FLEX GUIDE WIRE FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND REMOVAL, AND FORCE WAS APPLIED DURING REMOVAL .

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. 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 PERFORMED TO TREAT A LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. A CONNECT FLEX GUIDE WIRE WAS BEING USED WHEN THE TIP SEPARATED. THE SEPARATED TIP WAS EMBEDDED IN THE VESSEL USING AN UNSPECIFIED STENT. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761123 HI-TORQUE CONNECT GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 1012592 5026356 08717648175022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention