BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11391487 · Received March 1, 2021

    Report

    Report Number
    9681834-2021-00024
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 1, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 GUIDEWIRE M 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 IS LIKELY THAT THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH A SHARP DEVICE, SUCH AS A METAL NEEDLE, WHICH IS CONTRAINDICATION FOR THIS PRODUCT. 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 · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE WAS USED DURING THE PROCEDURE. DURING AN ATRIUM INTERVENTION; FEMORAL ACCESS, THE COATING OR A PIECE OF THE TERUMO WIRE WAS LEFT IN THE LUMEN VESSEL. AFTER A COMPUTED TOMOGRAPHY SCAN (CT) INVESTIGATION THEY NOTICED THAT THERE WAS A PIECE OF THE WIRE STILL INSIDE THE VESSEL. AFTER SEVERAL CALLS THE NEPHROLOGIST STATED THAT THE VASCULAR SURGEON REPORTED THAT THIS ISSUE HAPPENED BECAUSE OF A MISTAKE BY THE USER. IT MIGHT HAVE BEEN CAUSED BY A SHARP DEVICE AND A TOO STRONG PULLING OF THE WIRE, AND HE POINTED OUT THAT THIS WAS NOT A PRODUCT ISSUE BUT A USER ERROR. THEY WILL REMOVE THE PART DURING THE NEXT DAYS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292679 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention