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

Model Number	OL-XA35453M
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.Since the actual device was not returned, a detailed analysis could not be performed.History investigation of the involved product code and lot number no anomaly was found in the results of the history investigation.No similar event was found in the past complaint file.Based on the investigation results, no anomaly was found in the history of the involved product code/lot#.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: during use of the device in question for an ercp procedure the guidewire appeared frayed, making it impossible to use.Peeling was observed on the outer layer of the actual sample, and since the possibility of residual material remaining inside the body cannot be ruled out, the event was judged as a serious injury.The procedure outcome was not reported.There was no harm to the patient reported.

• Brand Name: VISIGLIDE
• 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: 24421907
• Report Number: 9681834-2026-00030
• Device Sequence Number: 10577289
• Product Code: OCY
• UDI-Device Identifier: 04953170282881
• UDI-Public: (01)04953170282881(17)271130(10)241209
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/23/2026

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-XA35453M
• Device Lot Number: 4ZK (241209)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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