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

Model Number	OL-XS35455M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: (b)(4) since the lot# was unknown, only di no.Is listed.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: unknown.E1: address: unknown.E1: telephone number: unknown.E2: health professional: unknown.E3: occupation: unknown.H4: device manufacture date: unknown due to unknown lot number.Since the actual device was not returned, a detailed analysis could not be performed.History investigation of the involved product code and lot number since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.Regarding the involved product, no similar issues attributable to the manufacturing process were reported in the past three years.Cause of occurrence/conclusion since the lot number was unknown, the investigation of manufacturing records and shipping inspection records could not be performed.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." terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Terumo medical corporation received the following reported information: visiglide 2 guidewire used during endoscopic retrograde cholangiopancreatography (ercp) procedure, the distal tip came off the guidewire and stayed in the ampulla.Biopsy forceps were used to retrieve the tip.The tip was removed from the patient's body.There were no adverse effects and no harm reported.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Since the infection status was unknown, it was not possible to open the actual device and confirm its condition.Appearance confirmation of the actual device through the package bag.- the actual device was inside a bag, and it was not possible to confirm its condition.History investigation of the involved product code and lot number - no anomaly was found in the results of the history investigation.Based on the investigation results, no anomaly was found in the manufacturing history records.Additionally, since the infection status of the actual device was unknown, a detailed investigation could not be conducted, and it was not possible to clarify the cause of occurrence.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).

• 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: 23606615
• Report Number: 9681834-2025-00212
• Device Sequence Number: 13241248
• Product Code: OCY
• UDI-Device Identifier: 04953170358258
• UDI-Public: (01)04953170358258(17)280430(10)250507
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Lot Number: 55K (250507)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown