BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIGLIDE2

    MDR report key: 24130435 · Received January 21, 2026

    Report

    Report Number
    9681834-2025-00256
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 24, 2025
    Report Date
    January 21, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    UDI-DI
    04953170358258
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: LOT NUMBER: 46K (ESTIMATED TO BE 240605, 240619, 240626, 240627). D4: UDI: UNKNOWN, ONLY DI NO. IS LISTED (B)(4). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: UNKNOWN. E1: PHONE NUMBER: UNKNOWN. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. H4: DEVICE MANUFACTURE DATE: ESTIMATED TO BE 05JUN2024, 19JUN2024, 26JUN2024 OR 27JUN2024. SINCE THE ACTUAL DEVICE WAS NOT RETURNED, DETAILED INVESTIGATION COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER. - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO SIMILAR EVENT WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. IN ADDITION, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND AN ANALYSIS COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE 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 GUIDEWIRE AND/OR ENDOTHERAPY DEVICE AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, HEMORRHAGE OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY DEVICE. (B)(4) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, STENT PLACEMENT DURING THE PROCEDURE, GUIDEWIRE SHOWED PEELING OFF PHENOMENON. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190085 VISIGLIDE2 ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XS35455M 04953170358258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other