BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX NITINOL GUIDEWIRE

    MDR report key: 6430963 · Received March 24, 2017

    Report

    Report Number
    2183870-2017-00143
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN
    Product Code
    DQX
    PMA / PMN Number
    K040345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. AS RECEIVED, THE DEVICE CONSISTED OF ONE EACH MJNCCA-X, STD 260-035; RETURNED LOADED IN A NO N-LRM DISPENSER ASSEMBLY AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY POUCHES. THE DEVICE PRESENTED WITH AN OVERALL LENGTH OF 259.70 CM FROM THE PROXIMAL ASPECT OF THE CORE WIRE FRACTURE, A SHAFT DIAMETER OF .03395" TO .03400", AND A PROXIMAL COIL TO CORE WIRE JOINT DIAMETER OF .03465". THE COIL SEGMENT WAS STRETCHED TO AN INDETERMINATE LENGTH. THE TIP DIMENSIONS COULD NOT BE MEASURED DUE TO THE DAMAGE TO THE DISTAL TIP REGION. THE DEVICE PRESENTED WITH A FRACTURE OF THE CORE WIRE 0.30 CM FROM THE DISTAL TIP WITH STRETCH DAMAGE TO THE COIL WRAPS. THE FRACTURE SHOWED INDICATIONS OF DUCTILE, TENSILE OVERLOAD. NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED TO THE SPECIMEN. BOTH JOINTS WERE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NONDESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE DEVICE WAS VISUALLY AND DIMENSIONALLY CORRECT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO USE A NITREX WIRE IN THE TREATMENT OF A PATIENT AT THE RIGHT DISTAL ANTERIOR TIBIAL ARTERY. TARGET LESION TYPE WAS CALCIFIED WITH 70% STENOSIS. PHYSICIAN REPORTED THAT THEY FELT SOME RESISTANCE WHEN INTRODUCING THE WIRE INTO THE BALLOON. PHYSICIAN RETRIEVED THE WIRE, WET IT AND THEN ATTEMPTED TO RE-INTRODUCE THE WIRE WELL INTO THE BALLOON.IT IS REPORTED THAT THE TIP DETACHED INSIDE THE 0.035" BALLOON. PHYSICIAN CHANGED TO A 0.014" COMPETITOR WIRE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214425 NITREX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX COVIDIEN 10619124

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR