MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA VISIGLIDE2; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	OL-XS35455M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
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.

• Brand Name: VISIGLIDE2
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24130435
• Report Number: 9681834-2025-00256
• Device Sequence Number: 14804396
• Product Code: OCY
• UDI-Device Identifier: 04953170358258
• UDI-Public: (01)04953170358258
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OL-XS35455M
• Device Catalogue Number: OL-XS35455M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown