BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 12834597 · Received November 18, 2021

    Report

    Report Number
    9681834-2021-00210
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 18, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    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

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. SIMULATION TEST: BASED ON EXPERIENCE AND STUDY, IT IS KNOWN THAT THE USE OF THE RADIFOCUS GUIDEWIRE M IN COMBINATION WITH A METAL NEEDLE MAY RESULT IN THE PEELING OF THE OUTER LAYER. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. IFU STATES: DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT. IT WAS LIKELY THAT WHEN THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH THE METAL NEEDLE, IT MIGHT HAVE BEEN MANIPULATED IN THE WITHDRAWAL DIRECTION, RESULTING IN THE PEELING OF THE OUTER LAYER. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. TO IMPLANT A PORT MADE BY ANOTHER COMPANY, THE GUIDEWIRE WAS USED IN COMBINATION WITH A METAL NEEDLE. LATER, RESULTS OF A CT SCAN FOR FOLLOW-UP, A 10 CM PIECE OF GUIDEWIRE WAS FOUND LEFT IN THE PERIPHERAL OF THE PULMONARY ARTERY. THE PATIENT HARM WAS NON-SERIOUS. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735817 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other