BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 17958581 · Received October 18, 2023

    Report

    Report Number
    9681834-2023-00201
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 19, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3: PATIENT SEX: 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 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. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K): K122590, K163004. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND NO ANOMALY SUCH AS PEELING OF THE OUTER LAYER. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND NO ANOMALY SUCH AS A SCRATCH OR FOREIGN SUBSTANCE. AFTER VISUAL INSPECTION OF THE DYEING CONDITION OF HYDROPHILIC COAT, NO ANOMALY SUCH AS PEELING OF THE HYDROPHILIC COAT WAS FOUND OVER THE ENTIRE LENGTH. THE OUTER DIAMETER MEASUREMENT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. SINCE THE LOT NUMBER WAS UNKNOWN, THE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE APPEARANCE AND DIMENSIONS OF THE ACTUAL SAMPLE. THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM THE BLACK PEELED SECTION THAT WAS DESCRIBED IN THE REPORTED ISSUE ON THE ACTUAL SAMPLE. THE PEELED SECTION THAT WAS DESCRIBED IN THE REPORTED ISSUE WAS NOT LIKELY TO BE DERIVED FROM THE INVOLVED PRODUCT, AND THE CAUSE OF OCCURRENCE COULD NOT BE IDENTIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "WARNINGS 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 GLIDEWIRE WAS USED WITHOUT ANY PROBLEMS DURING THE PROCEDURE. HOWEVER, WHEN THE PRODUCT WAS LOOKED AT CLOSELY AFTER THE PROCEDURE, THE BLACK PEELED SECTION WAS FOUND. IT WAS UNCLEAR WHAT HAD PEELED OFF. IT CANNOT BE DENIED THAT THE PEELED PIECE REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT SERIOUSLY HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538930 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other