BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 14434355 · Received May 19, 2022

    Report

    Report Number
    9681834-2022-00092
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 18, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, OCCUPATION: PHARMACIST PMA/510(K): K062858, K082644. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED TO (B)(4) FACTORY, AN INVESTIGATION OF THE SAMPLE WAS UNABLE TO BE PERFORMED. THE ATTACHED IMAGE WAS CONFIRMED. IT WAS FOUND THAT THE DISTAL END OF DILATOR WAS FRACTURED AND WAS SEPARATED INTO TWO PARTS. HOWEVER, THE DETAILED STATE OF FRACTURED SECTION AT THE DISTAL END OF DILATOR COULD NOT BE CONFIRMED FROM THE IMAGE. A REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS. SINCE THE CONDITION OF ACTUAL PRODUCT COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU REFERENCE: "WARNING AND PRECAUTIONS: PRECAUTIONS: DO NOT USE IF THE UNIT PACKAGE OR THE PRODUCT HAS BEEN DAMAGED OR SOILED." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHILE THE PHYSICIAN WAS PREPARING THE INTRODUCER INVOLVED, THE WIRE WAS PLACED OVER WHEN IT WAS NOTICED THAT THE TIP WAS BROKEN. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816074 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA N/A 210908

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown