BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10526980 · Received September 14, 2020

    Report

    Report Number
    9681834-2020-00184
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 14, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. PMA/510(K)- K926214. (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. REPRODUCTIVE TESTING WAS PERFORMED, AND A GUIDEWIRE WAS WITHDRAWN FROM A METAL NEEDLE. AS A RESULT, THE URETHANE OUTER LAYER OF THE GUIDEWIRE WAS PEELED OFF. THE CROSS-SECTION SURFACE OF THE URETHANE WAS SMOOTH AS IF IT HAD BEEN CUT WITH A BLADE, AND EXPOSED CORE WIRE WAS OBSERVED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OF THE SHIPPING INSPECTION RECORD. IFU STATES: DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE ADVANTAGE 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 GUIDEWIRE WAS EXPOSED TO A PULLING LOAD IN THE WITHDRAWAL DIRECTION WHILE ITS URETHANE COATING WAS IN CONTACT WITH THE METAL NEEDLE, RESULTING IN THE PEELING OF URETHANE OUTER LAYER. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PTCD, AND THE URETHANE OUTER LAYER WAS PEELED OFF AND A FRAGMENT WAS LEFT IN THE PATIENT. THE PATIENT HAS NOT BEEN SERIOUSLY IMPACTED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995473 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other METAL NEEDLE