BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE M

    MDR report key: 20266286 · Received September 20, 2024

    Report

    Report Number
    9681834-2024-00164
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 20, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: PMA/510(K): K923607, K926214. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER · SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. · REGARDING THE INVOLVED PRODUCT CODE, THERE HAVE BEEN NO REPORTED ISSUES ATTRIBUTABLE TO THE MANUFACTURING PROCESS IN THE PAST TWO YEARS. CAUSE OF OCCURRENCE/CONCLUSION. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLLDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 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 DURING PEDIATRIC SURGERY THEY USED A GUIDE WIRE M 0.035""X150CM RF*GA35153M FOR IMPLANTATION OF A HEMODIALYSIS CATHETER. THE COATING OF THE GUIDEWIRE CAME OFF, DURING THE PULLING BACK OF THE WIRE THROUGH THE SHARP CANNULA. A PART OF THE COATING IS STILL INSIDE THE VEIN OF THE CHILD AND IS NOT REACHABLE THROUGH SURGICAL OR ENDOVASCULAR APPROACH. LOT NUMBER IS AT THE MOMENT NOT KNOW, AS WE COULD NOT CONTACT THE RESPONSIBLE PHYSICIAN. POTENTIAL HARM DUE TO DETACHED COATIN INSIDE THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226528 RADIFOCUS GLIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF*GA35153M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other