BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 19333112 · Received May 16, 2024

    Report

    Report Number
    9681834-2024-00085
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 16, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . G4: 510(K): K923607, K926214 SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. 1. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER · SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. · IN THE PAST TWO YEARS FOR THE PRODUCT WITH THE INVOLVED PRODUCT CODE, WE HAVE NOT RECEIVED ANY COMPLAINTS CAUSED BY THE MANUFACTURING PROCESS. 2. CAUSE OF OCCURRENCE/CONCLUSION SINCE THE LOT# WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING GASTROENTEROLOGICAL ENDOSCOPY (ERCP), IT WAS FOUND THAT THE DISTAL END OF GUIDEWIRE WAS FRACTURED. THERE ARE CURRENTLY NO SCHEDULES TO MAKE AN INCISION AND REMOVE THE FRACTURED PIECE FROM THE PATIENT'S BODY, AND THE SITUATION WILL BE MONITORED FOR THE TIME BEING. THE FRACTURED PIECE REMAINS IN THE PATIENT'S BODY, IT WAS NOT RETRIEVABLE. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925145 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other