BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIGLIDE

    MDR report key: 23286259 · Received October 15, 2025

    Report

    Report Number
    9681834-2025-00193
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 13, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 250122 & 250123 & 250124, D4: DI: (B)(4), D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, G4: PMA/510(K): EXEMPT . THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. ASHITAKA FACTORY HAS BEEN MAKING EFFORTS IN MAINTAINING THE QUALITY OF THE PRODUCT BY PERFORMING FOLLOWING INITIATIVES. IN THE MANUFACTURING PROCESS, THE OUTER DIAMETER OF WIRE IS CONTROLLED TO ASSURE ITS STRENGTH. IN THE PRODUCT ASSEMBLING PROCESS, 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO ANOMALY SUCH AS A SCRATCH. BEFORE THE PACKAGING PROCESS, 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO ANOMALY SUCH AS A SCRATCH. AS A SHIPPING INSPECTION, PULLING STRENGTH OF THE DISTAL END IS MEASURED ON SAMPLING BASIS FOR EACH LOT. THE INSTRUCTIONS FOR USE (IFU) OF THIS PRODUCT INCLUDES THE FOLLOWING WARNING: "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." PLEASE REFER TO SECTION H10 FOR THE IMPORTER'S REPORT ON THE REPORTED EVENT. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT: "PATIENT WAS UNDERGOING ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY], AND AN ATTEMPTED EUS-GUIDED [ENDOSCOPIC ULTRASOUND] RENDEZVOUS WAS UNSUCCESSFUL AS THE WIRE COULD NOT CROSS THE DISTAL STRICTURE. INITIAL ATTEMPT WAS COMPLICATED BY SHEARING OF THE WIRE WITH PART OF THE WIRE SHEATH BEING LEFT WITHIN THE PATIENT'S COMMON HEPATIC DUCT. THIS COULD NOT BE REMOVED." ADDITIONAL INFORMATION WAS RECEIVED ON 25SEP2025: THE SIZE OF SHEARED WIRE THAT WAS LEFT WITHIN THE PATIENT'S COMMON HEPATIC DUCT WAS UNSURE; IT WAS FROM SHEARING OF THE 0.025 STRAIGHT VISIGLIDE WIRE; PART OF THE WIRE SHEATH COATING THE WIRE (NOT THE METAL PORTION) CAME OFF AND FLOATED UPSTREAM INTO THE COMMON HEPATIC DUCT. IT WAS FELT TO BE UNSAFE TO TRY TO RETRIEVE THE WIRE SHEATH, THEREFORE NO ATTEMPTS WERE MADE. THE PATIENT WAS STABLE AND RELEASED BACK TO INPATIENT BED FOLLOWING PROCEDURE AND WAS RELEASED HOME ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184999 VISIGLIDE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA G-240-2545S 51K

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other