BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 18978950 · Received March 26, 2024

    Report

    Report Number
    9681834-2024-00039
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 26, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3A: SEX: REQUESTED, NOT PROVIDED A3B: GENDER: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT NUMBER: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: ESTABLISHMENT ADDRESS: REPUBLIC OF KOREA 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. ALTHOUGH IT WAS DESCRIBED IN THE REPORTED ISSUE "DEFECTIVE TIP", IT WAS NOT POSSIBLE TO DETERMINE THE SPECIFIC CONDITION OF ANOMALY IN THE ACTUAL SAMPLE FROM THE DESCRIPTION. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COULD NOT BE REVIEWED. REGARDING THE PRODUCT WITH THE INVOLVED PRODUCT CODE, NO OTHER SIMILAR COMPLAINT DUE TO MANUFACTURING DEFECTS WAS REPORTED IN THE PAST TWO YEARS. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT COULD NOT BE REVIEWED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE DOCTOR REQUESTED AN EXCHANGE OF THE INVOLVED RADIFOCUS GLIDEWIRE DUE TO A DEFECTIVE TIP DURING THE TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4519 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown