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

Model Number	OL-XS35455M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the reported information.On tuesday, (b)(6) 2025, during an ercp procedure, a visiglide 0.035 straight guidewire was used.From the beginning, the guidewire was unusable due to damage to the coating.The coating appeared to be defective, which caused the wire to become stuck inside the extraction balloon.As a result, the medical team was forced to use a second guidewire for the same patient.The procedure outcome was not reported; however, the patient was not harmed.
Additional Manufacturer Narrative
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: unknown due to unknown lot number.Since the actual device was not returned, detailed investigation could not be performed.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.In the past three years, we have not received any similar complaints of the involved products caused by the manufacturing process.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.In addition, 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.Relevant instructions for use (ifu) reference: "before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, present an infection control risk, cause tissue irritation and patient injury, such as perforation, hemorrhage, mucous membrane damage or thermal injury and may result in more-severe equipment damage." "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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in sections b5, d4 and h4, the device return date in section d9, additional information to section b5, update section h3, and to provide the completed investigation results.Visual and microscopic inspections of the actual device: the outer layer had been peeled off in an accordion shape at approximately 50mm - 63mm from the distal end.The wire had been exposed at approximately 63mm - 73mm from the distal end.The tapered ring was in a state where it could move at approximately 63mm - 73mm from the distal end.It had been intermittently abraded at approximately 73mm - 89mm from the distal end.No anomaly such as a scratch or peeling was found in other sections.Confirmation of dimensions - outer diameter of the urethane outer layer: it was not possible to measure it.Outer diameter of the ptfe outer layer: it met the factory's specifications.No anomaly was found.No anomaly was found in the history investigation result.No other similar report was found in the past complaint file.Confirmation on the manufacturing process: at the manufacturing process, the fixing strength of the tapered ring had been inspected.No anomaly was found in the fixing strength of the involved lot.At the manufacturing process, 100% visual inspection is performed to confirm that there is no anomaly such as a scratch or exposure of the wire in the urethane part at the distal end and in the tapered ring.At the manufacturing process, the outer diameter is measured on 100% basis to confirm that there is no anomaly in the outer diameter of urethane part at the distal end.
Event or Problem Description
Terumo received the following reported information: the procedure was prolonged; less than 30 minutes.

• 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: 23414352
• Report Number: 9681834-2025-00203
• Device Sequence Number: 9084614
• Product Code: OCY
• UDI-Device Identifier: 04953170358258
• UDI-Public: (01)04953170358258(17)271231(10)250106
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OL-XS35455M
• Device Catalogue Number: G-260-3545S
• Device Lot Number: 51K (250106)
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 04/13/2026; 05/05/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 05/05/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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
• Patient Sex: Unknown