BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 10851265 · Received November 17, 2020

    Report

    Report Number
    9681834-2020-00240
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    August 24, 2020
    Report Date
    November 17, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 05K PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER IMPLANTED DATE: DEVICE WAS NOT IMPLANTED EXPLANTED DATE: DEVICE WAS NOT EXPLANTED DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER HEALTH PROFESSIONAL- REQUESTED, NOT PROVIDED OCCUPATION- REQUESTED, NOT PROVIDED NAME- REQUESTED, NOT PROVIDED THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. BASED ON THE REPORTED LOT NUMBER 05K, IT WAS CONFIRMED THAT OL-XS25455M BATCHED IN MAY 2020 WAS LOT 200526 ONLY. FROM THIS, THE LOT NUMBER INVOLVED IN THIS COMPLAINT WAS CONCEIVABLE TO BE 200526. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION OL-XS25455M/200526 WAS CONDUCTED WITH NO FINDINGS. IT IS LIKELY THAT THE ACTUAL SAMPLE IN THE STATE OF ITS DISTAL TIP BEING TRAPPED DUE TO SOME FACTORS MIGHT HAVE BEEN SUBJECTED TO AN EXCESSIVE LOAD (TENSILE, TORQUE, BENDING, ETC.), RESULTING IN THE SEPARATION OF THE DISTAL TIP. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. PLEASE SEE MDR 2243441-2020-00064 FOR THE IMPORTER REPORT. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TIP BROKE OFF THE VISIGLIDE 2 IN THE PATIENT, IT WAS ABLE TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2020. THERE PATIENT WAS NOT HARMED. THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317879 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention