BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 10205327 · Received June 29, 2020

    Report

    Report Number
    9681834-2020-00117
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 29, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. LOT NUMBER: REQUESTED, NOT PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL- REQUESTED, NOT PROVIDED. OCCUPATION- REQUESTED, NOT PROVIDED. 510(K): K062858, K082644. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OR THE SHIPPING INSPECTION RECORD. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. IT IS LIKELY THAT THE COMPETITOR'S CUTTING BALLOON MAY NOT HAVE BEEN DEFLATED COMPLETELY BEFORE BEING PULLED OUT; DUE TO THIS, THE ACTUAL SAMPLE MIGHT HAVE BEEN EXPOSED TO A BLADE OF THE CUTTING BALLOON WITH RESULTANT TEAR ON THE SHEATH TUBE. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER WAS USED DURING THE PROCEDURE. BLEEDING AT THE PUNCTURE SITE AND WAS ABLE TO BE STOPPED QUICKLY. THERE WERE NO CONSEQUENCES FOR THE PATIENT; THE PATIENT WAS NOT HARMED. A CUTTING BALLOON WAS USED AND WENT THROUGH THE INTRODUCER WHICH POSSIBLY DAMAGED THE INTRODUCER. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671744 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1