BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10216927 · Received July 1, 2020

    Report

    Report Number
    9681834-2020-00118
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 1, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1. THIS REPORTED EVENT HAS BEEN DEEMED NOT REPORTABLE BASED UPON THE RETURNED SAMPLE. IT WAS CONFIRMED THAT THERE WAS NO TERUMO ASHITAKA-MADE PRODUCT INVOLVED IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K926214. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD ND SHIPPING INSPECTION RECORD. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. APPROXIMATELY 2CM DISTAL TIP OF THE TERUMO 035" X 150CM STRAIGHT TIP GWM BROKE OFF DURING END OF THE URETERIC STENT PROCEDURE. APPROXIMATELY 2CM TIP WAS OBSERVED BY THE UROLOGY REGISTRAR TO BE BROKEN OFF WHEN REMOVING THE GUIDEWIRE THROUGH THE COOK CATHETER FROM URETER. THE UROLOGY REGISTRAR PERFORMING THE PROCEDURE REMOVED ALL THE GUIDE WIRE PIECES FROM THE PATIENT; DISTAL TIP AND REMAINING PROXIMAL GUIDE WIRE. THE PROCEDURE OUTCOME AND THE FINAL PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681591 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK CATHETER