BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 14786109 · Received June 23, 2022

    Report

    Report Number
    9681834-2022-00121
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 23, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. PATIENT SEX: REQUESTED, NOT PROVIDED. WEIGHT: REQUESTED, NOT PROVIDED. ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER: UNKNOWN. OCCUPATION: DOCTOR. PMA/510(K) - K122590, K163004. THE ACTUAL SAMPLE WAS NOT RETURNED; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER SIMILAR REPORTS WITH THE INVOLVED PRODUCT/LOT NUMBER COMBINATION FROM OTHER FACILITIES. ACCORDING TO THE RESULT OF INVESTIGATION, NO ANOMALY WAS NOTED IN THE MANUFACTURING RECORD OR THE SHIPPING INSPECTION RECORD. HOWEVER, IN THIS CASE, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE DETAILS OF THE OCCURRENCE WERE UNKNOWN, WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN THE RADIOFOCUS GUIDEWIRE ADVANTAGE WAS REMOVED FROM THE PACKAGING, ROUGHLY 0.5CM OF THE TIP HAD BROKEN OFF. THE WIRE WAS NOT USED, NOR DID IT ENTER THE PATIENT. THE PROCEDURE CONTINUED WITH AN ALTERNATIVE NON-TERUMO WIRE WITHOUT COMPLICATION. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307678 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A 211105

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GORE AAA EVAR CASE USING GORE DEVICE AND 035"" GWA