BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 21217198 · Received January 23, 2025

    Report

    Report Number
    9681834-2025-00004
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 23, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3A: SEX: REQUESTED, NOT PROVIDED A3B: GENDER: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT NUMBER: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: REPORTER NAME : REQUESTED, UNKNOWN E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN E3: OCCUPATION: REQUESTED, UNKNOWN H4: DEVICE MANUFACTURE DATE: REQUESTED, NOT PROVIDED 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. SINCE THE LOT NUMBER WAS UNKNOWN, IT COULD NOT BE INVESTIGATED. IN THE PAST TWO YEARS, WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS OF THE INVOLVED PRODUCTS CAUSED BY THE MANUFACTURING PROCESS. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: ESTIMATED TO BE 240909, 240919, 240920, 240924, 240925, 240927. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION TO SECTION D4, LOT NUMBER AND EXPIRATION DATE, PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. SINCE THE ACTUAL SAMPLE WAS NOT KNOWN TO BE INFECTIOUS, IT WAS NOT POSSIBLE TO OPEN THE PACKAGE AND CONFIRM THE CONDITION OF ACTUAL SAMPLE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE CONDITION OF ACTUAL SAMPLE COULD NOT BE INSPECTED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDOTHERAPY 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 ENDOTHERAPY ACCESSORY."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EXAMINATION) PROCEDURE, WHEN THE DOCTOR WAS INSERTING (B)(6) INTO THE PATIENT'S BODY (FROM THE PAPILLA TO THE BILE DUCT), HE NOTICED THAT IT WAS NOT SLIDING SMOOTHLY. THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY AND INSPECTED, AND IT WAS FOUND THAT THE COATING HAD BEEN PEELED OFF. THEREFORE, THE PRODUCT WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY; HOWEVER, THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489675 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XA25455 49K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other