BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THRUWAY GUIDE WIRE

    MDR report key: 4143255 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05958
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K042338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDE WIRE REMOVAL DIFFICULTIES OCCURRED. THE 100%, CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED POSTERIOR TIBIAL ARTERY (PTA). AFTER A NON-BSC GUIDE WIRE CROSSED THE TARGET LESION, A 190CM THRUWAY GUIDE WIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION AS A SUPPORT WIRE. THE NON-BSC GUIDE WIRE WAS USED TO CROSS THE ANTERIOR TIBIAL ARTERY (ATA). THE PHYSICIAN EXCHANGED THE GUIDE WIRES IN THE ATA AND THE PTA USING A 0.014 NON-BSC MICRO CATHETER. IT WAS NOTED THAT THE 190CM THRUWAY GUIDE WIRE WAS STUCK WITH THE NON-BSC MICRO CATHETER AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE DEVICES WERE PULLED AND WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, IT WAS ALSO NOTED THAT THE 190CM THRUWAY GUIDE WIRE WAS STRETCHED APPROXIMATELY 15CM FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH 2 NON-BSC DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624978 THRUWAY GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001492921 0010398847

    Patients

    Seq Age Sex Outcome Treatment
    1