MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA VISIGLIDE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	OL-XS25455
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the guidewire broke inside the duct.
Additional Manufacturer Narrative
Implanted date - device not implanted.Explanted date - device not explanted.Occupation: unknown.Inspection of the actual sample could not be performed since it was not returned to ashitaka factory.The product code reported (ol-xs25455) was for a domestic destination, we inquired at the involved facility and identified it.Our follow-up with the involved facility obtained the following information.The product appeared to have been fragmented and the fragment appeared to be about 25 mm under an x-ray fluoroscope.Retrieval of the fragment was abandoned.Review of the manufacturing record and the product-release judgment record of the involved product/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination from other facilities.The investigation results showed that there was no anomaly in the manufacturing related records.Since the actual sample was not returned, close analysis of it could not be performed.The cause of occurrence could not be clarified.The following statement can be found in the instructions for use (ifu) of this product: "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.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section g4.This device is exempt from the 510k; therefore, section g4 should have been left blank.

• Brand Name: VISIGLIDE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15350036
• Report Number: 9681834-2022-00170
• Device Sequence Number: 14759074
• Product Code: DQX
• UDI-Device Identifier: 04953170358234
• UDI-Public: 04953170358234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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-XS25455
• Device Catalogue Number: G-260-2545S
• Device Lot Number: 1YK (211122)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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