BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 7391719 · Received April 3, 2018

    Report

    Report Number
    9681834-2018-00042
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 3, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. BASED ON THE COMPLAINT DESCRIPTION, IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO A WITHDRAWAL MANIPULATION IN THE STATE WHERE ITS URETHANE OUTER LAYER HAD CONTACT WITH THE METALLIC NEEDLE USED IN COMBINATION WITH THE ACTUAL DEVICE. AS THE RESULT, THE URETHANE OUTER LAYER MAY HAVE GOT SHEARED OFF THE WIRE. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING:DO NOT MANIPULATE OR WITHDRAW THE RADIFOCUS GLIDEWIRE ENDOSCOPIC(UROLOGIC) WIRE THROUGH A METAL ENTRY NEEDLE, METAL DILATOR OR METAL DEVICES WITH SHARP OR RASPING EDGES. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL DEVICE WITH SHARP OR RASPING EDGES 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. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED DURING THE USE OF THE ACTUAL SAMPLE WITH A METALLIC NEEDLE, THE URETHANE OUTER LAYER SHEARED OFF THE ACTUAL SAMPLE INSIDE THE HEPATIC ARTERY AND REMAINED IN THE BODY. IT IS UNKNOWN AT THIS STAGE IF AN ATTEMPT WILL BE MADE TO REMOVE THE SHEARED PIECE FROM THE BODY. THE INVOLVED DR. REPORTED THAT THERE HAS NOT BEEN ANY HARM ON THE INVOLVED PATIENT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235352 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEEDLE (METALLIC)| NEEDLE (METALLIC)