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
Event or Problem Description
Terumo medical corporation received the following reported information: the coating was coming off.The procedure outcome was not reported.There was no harm to the patient reported.
Additional Manufacturer Narrative
D4: expiration date: unknown due to the lot number being unknown.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.H4: device manufacture date: unknown due to the lot number being unknown.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.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.As the lot number was unknown, the manufacturing record and the shipping inspection record of the actual device could not be investigated.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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.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 in a holder tube.Although no anomaly such as peeling of the outer layer was found in appearance within the range that could be seen through the package bag, it was not possible to confirm the details.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#.Furthermore, since the actual device could not be analyzed in detail, it was not possible to clarify the cause of occurrence.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 23802650
• Report Number: 9681834-2025-00226
• Device Sequence Number: 18041434
• 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): 12/15/2025

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 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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