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

Model Number	GR3508
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: procode: dqx & gcj.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: establishment name: requested, not available due to confidentiality.E1: establishment address: requested, not available due to confidentiality.E1: reporter name: requested, not available due to confidentiality.E1: phone number: requested, not available due to confidentiality.The actual sample has not been received.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the product with the product code/lot# involved confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the product code/lot# involved from other facilities.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
Terumo medical obtained an fda medwatch report # mw5157027.The event description states: that a tips procedure was carried out, during which a 180cm angled glidewire with a hydrophilic coating was utilized.During the process, part of the coating detached from the wire within the liver.The stripped coating is visible under fluoroscopy and, being irretrievable, remains in the liver.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3 and to provide the completed the completed investigation results.The actual device is no longer available for returned; therefore, an evaluation of the actual device was unable to be conducted.History investigation of the product with the product code/lot # involved.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report has been found in the past.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual sample was not returned and investigation of it could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory assures the quality of this product by performing following controls.100% insertion inspection is performed by passing a guidewire through the dedicated tool to confirm that there is no anomaly such as peeling of the outer layer or adhesion of the foreign substance on the surface of guidewire.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as exposure of the wire or appearance abnormalities.The instructions for use (ifu) of this product includes the following warning: [warnings] if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire m and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the guide wire m or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 20158765
• Report Number: 9681834-2024-00160
• Device Sequence Number: 8369092
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197(17)250930(10)231017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 231017
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG