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

Model Number	OL-XA25455M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: di: (b)(4) d6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: unknown.E1: establishment name: unknown.E1: address: unknown.E1: phone number: unknown.E2: health professional: unknown.E3: occupation: unknown.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.Complaint files from the past three years were investigated.No deviations or non-conformities related to the manufacturing process for the involved case were found.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 reported information.The coating was coming off.The procedure outcome was not reported.There was no patient injury, and no medical or surgical intervention required.No equipment or other devices were used with the product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to sections d4 and h4, the device return date in section d9, 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 outer layer had peeled off at the distal end (peeled part: approximately 22mm).No anomalies such as abrasion or peeling of the outer layer were found in appearance of other parts within the range that could be seen through the package bag.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 number.Furthermore, since the actual device could not be analyzed in detail, it was not possible to clarify the cause of occurrence.Relevant 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.".

• 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: 23816685
• Report Number: 9681834-2025-00233
• Device Sequence Number: 13114064
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: (01)04953170358241(17)271130(10)241204
• 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
• Report Date (Section B): 12/16/2025

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-XA25455M
• Device Catalogue Number: G-260-2545A
• Device Lot Number: 241204
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Patient Sex: Unknown