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	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number: 231109 or 231114 or 231115 or 231116.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: manufacturing date: 11/09/2023 or 11/14/2023 or 11/15/2023 or 11/16/2023.The actual sample was discarded by the involved facility.Since the actual sample was not returned, the investigation of it could not be performed.No anomaly was found in the manufacturing record and the shipping inspection record.No similar issue has been reported from other facilities.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.In addition, no actual sample ware returned and the investigation of it could not be performed; therefore, it was impossible 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.(b)(4) 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 part of the guide wire used had been stripped, preventing the device from being fitted during the work.The event did not result in patient injury and/or require medical or surgical intervention required.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: 20771564
• Report Number: 9681834-2024-00218
• Device Sequence Number: 18176918
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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 Model Number: G-240-2545S
• Device Catalogue Number: OL-XS25453M
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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