BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .038 MC J3MM 150CM TEF

    MDR report key: 14402885 · Received May 14, 2022

    Report

    Report Number
    1016427-2022-05407
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    March 3, 2022
    Report Date
    June 17, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE IS RELATED TO MANUFACTURER REPORT NUMBER1016427-2022-05396. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FILE IS RELATED TO MANUFACTURER REPORT NUMBER 1016427-2022-05396. AS REPORTED, THE COATING OF THE EMERALD DIAGNOSTIC GUIDEWIRE DGW .038 MC J3MM 150CM TEF WAS PEELING OFF. THERE WAS NO REPORTED PATIENT INJURY. THREE ADDITIONAL EMERALD DIAGNOSTIC GUIDEWIRES WITH DELAMINATION WERE ALSO REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT RELATED TO THESE THREE WIRES. TWO IMAGES WERE PROVIDED FOR ANALYSIS. IN THE FIRST PICTURE, THE MOVABLE CORE AREA OF THE GUIDE WIRE IS VISIBLE WITH NO DAMAGES OR ANOMALIES NOTED. THE PRODUCT LABEL IS SHOWN IN THE SECOND PICTURE INDICATING THE PRODUCT IS AN EMERALD GUIDEWIRE WITH MOVABLE CORE, LOT NUMBER 352632375, CATALOGUE NUMBER 502-570. TWO ¿DGW .038 MC J3MM 150CM TEF¿ WERE RECEIVED FOR ANALYSIS AND WERE EVALUATED UNDER (B)(4). THE FIRST WIRE WAS A NON-STERILE DEVICE. NO DAMAGES WERE NOTED DURING VISUAL INSPECTION. THE SECOND WIRE WAS A STERILE DEVICE, WHICH WAS RECEIVED IN THE ORIGINAL POUCH. THE SEALS OF THE PACKAGING ARE INTACT, AND THE STERILITY WAS NOT COMPROMISED. THE DEVICE WAS THOROUGHLY INSPECTED, AND NO DAMAGES OR ANOMALIES WERE OBSERVED. ALL FOUR DEVICES HAVE THE SAME LOT NUMBER. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 352632375 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿COATING-WIRES -DELAMINATED¿ WAS NOT CONFIRMED. THE RETURNED GUIDEWIRE DOES NOT PRESENT ANY DAMAGES OR ANOMALIES RELATED TO THE COATING. THE IMAGE PROVIDED OF THE SUSPECTED DELAMINATED AREA WAS THE MOVABLE CORE WITH NO DAMAGES NOTED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿PROCEDURES REQUIRING PERCUTANEOUS CATHETER/GUIDEWIRE INTRODUCTION SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. TO LENGTHEN THE FLEXIBLE SEGMENT OF A MOVABLE CORE GUIDEWIRE, GENTLY WITHDRAW THE CORE. TO SHORTEN THE FLEXIBLE SEGMENT, PUSH THE CORE IN CAREFULLY.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE COATING OF THE EMERALD DIAGNOSTIC GUIDEWIRE DGW .038 MC J3MM 150CM TEF WAS PEELING OFF. THERE WAS NO REPORTED PATIENT INJURY. THE IMAGES PROVIDED FOR REVIEW REVEALED A WIRE WITH CORE EXPOSED (IMAGE1) AND A PACKAGING OF EMERALD DIAGNOSTIC GUIDEWIRE LOT 35262375 (IMAGE 2). THERE WAS NO PATIENT INVOLVEMENT. THREE (3) ADDITIONAL COMPLAINTS WILL BE ADDED TO THE FILE BASED ON ADDITIONAL INFORMATION PROVIDED BY THE REP INVOLVING DELAMINATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889485 DGW .038 MC J3MM 150CM TEF WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 35262375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown