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

Model Number	G-240-2545S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Our inspection of the returned sample upon receipt found that it does not have any anomaly.This complaint has turned to be "not reportable" because the device involved in this complaint has been verified to be the normal product.
Additional Manufacturer Narrative
D4: lot number: 230805 or 230828.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: reporter name: requested, unknown.E1: phone number: requested, unknown.E2: health professional: requested, unknown.E3: occupation: requested, unknown.H4: manufacturing date: 08/05/2023 or 08/28/2023.The actual sample was discarded by the involved facility.Since no actual sample was returned, investigation of it could not be performed.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.Since the actual sample was not returned and investigation of it could not be confirmed, it was not possible to clarify the cause of 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 guide wire and/or endotherapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the guide wire peeled off even though it has not been introduced into the endoscope operating channel.Another guide wire was taken before starting the procedure.The event occurred pre-treatment and there was no patient involved.There was no patient injury notified by the customer.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: VISIGLIDE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20771553
• Report Number: 9681834-2024-00207
• Device Sequence Number: 8136954
• Product Code: OCY
• UDI-Device Identifier: 04953170282782
• UDI-Public: (01)04953170282782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/25/2024

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 Expiration Date: 07/31/2026
• Device Model Number: G-240-2545S
• Device Catalogue Number: OL-XS25453M
• Device Lot Number: 38K
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 02/20/2025
• 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
• Patient Sex: Unknown