BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDWIRE

    MDR report key: 10257902 · Received July 10, 2020

    Report

    Report Number
    9681834-2020-00139
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    May 25, 2020
    Report Date
    July 10, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: SUBJECTED LOTS: 200109, 200110, 200115, 200124, 200127, AND 200128 WHICH WERE MANUFACTURED IN JANUARY 2020. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER; ESTIMATED DATE: 31DEC2022. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE JUDGEMENT RECORD OF THE PRODUCT CODE/ SUBJECTED LOT#'S COMBINATIONS WERE CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDO THERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDO THERAPY ACCESSORY. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED SINGLE USE GUIDEWIRE WAS USED DURING THE PROCEDURE. THE GUIDEWIRE BECAME CUT DURING EXCHANGING PROCESS IN ERCP PROCEDURE. IT WAS BROKEN DURING A SECOND PROCEDURE OF ERCP WHILE EXCHANGING THE DEVICE WITHIN T JF-Q180. THE PROBLEM HAPPENED DUE TO MISHANDLING OF THE PRODUCT AND AN UNTRAINED TECHNICIAN AT THE HOSPITAL. THE PROCEDURE OUTCOME AND FINAL PATIENT IMPACT WAS NOT REPORTED. SINCE THE GUIDEWIRE WAS BROKEN DURING THE PROCEDURE, IT WAS SUSPECTED THAT IT FELL OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723700 SINGLE USE GUIDWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TJF-Q180