BEUDAMED
    FDA Adverse Event Injury Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 7223161 · Received January 26, 2018

    Report

    Report Number
    2024168-2018-00637
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 21, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DETACHMENT WAS ABLE TO BE CONFIRMED. THE REPORTED FAILURE TO ADVANCE THE DEVICE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT AS THE GUIDE WIRE WAS ADVANCED, RESISTANCE WAS MET WITH THE HEAVILY CALCIFIED ANATOMY RESULTING IN THE REPORTED FAILURE TO ADVANCE. MANIPULATION OF THE DEVICE AND/OR INTERACTION WITH THE HEAVILY CALCIFIED ANATOMY RESULTED IN THE NOTED MULTIPLE CORE BENDS AND ULTIMATELY RESULTED IN THE REPORTED TIP DETACHMENT. AS REPORTED, THE TIP WAS STUCK IN CALCIUM AND THE DECISION WAS MADE TO LEAVE THE TIP IN THE ANATOMY. NO ATTEMPT WAS MADE TO REMOVE THE TIP. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. THE COMMAND GUIDE WIRE FAILED TO CROSS THE TARGET LESION DUE TO THE PATIENT ANATOMY. THE GUIDE WIRE WAS REMOVED WITHOUT ISSUE AND WAS REPLACED WITH A WINN GUIDE WIRE (LOT 7081171). THE WINN GUIDE WIRE FAILED TO CROSS THE TARGET LESION DUE TO THE PATIENT ANATOMY; THE TIP OF THE GUIDE WIRE BROKE OFF AS IT HIT THE CALCIFICATION DURING ADVANCEMENT. THE TIP WAS STUCK IN CALCIUM AND THE DECISION WAS MADE TO LEAVE THE TIP IN THE ANATOMY. NO ATTEMPT WAS MADE TO REMOVE THE TIP. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66849 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 7081171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other