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

Model Number	GS3506
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to patient confidentiality.A2: age & date of birth: requested, not provided due to patient confidentiality.A3a: sex: requested, not provided due to patient confidentiality.A4: weight: requested, not provided due to patient confidentiality.A5: ethnicity: requested, ot provided due to patient confidentiality.A6: race: requested, not provided due to patient confidentiality.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: requested, unknown.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Please refer to section h10 for the related reports.Terumo medical corporation (tmc) (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 corporation received the following reported information: during a nephroureterectomy drain insertion, the coating on the stiff glidewire peeled off inside the metal cannula stiffener for the drain.We were able to retrieve the coating that peeled off.There was no blood loss.There was no serious harm reported.The device defect was observed prior to use.There was no prolonged care.Additional information as received on 04nov2025: the patient was stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however an image was provided.An object that appears to be a peeled fragment of the outer layer was observed.A part was observed where the outer layer had peeled off and the wire strand was exposed in the main part.History investigation of the involved product code and lot number no anomaly was found in the manufacturing record and the shipping inspection record.No similar event was found in the past complaint file.Based on the investigation results, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual device was not returned and analysis could not be performed, it was not possible to identify the cause of the occurrence.Ashitaka factory is committed to maintaining the quality of the product by performing following control and inspection.The guidewire is passed through the dedicated tool on 100% basis to ensure that there is no peeling of the outer layer or adhesion of any foreign matters on the surface of the guidewire.Before the packaging process, 100% visual inspection is performed to ensure that there are no anomalies in appearance such as a peeling of the outer layer or an exposure of the wire strand.The ifu indicates the following: do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire 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.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: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 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: 23646447
• Report Number: 9681834-2025-00218
• Device Sequence Number: 15959412
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: (01)04987350773593(17)261231(10)250107
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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 Model Number: GS3506
• Device Catalogue Number: RF*PA35153A
• Device Lot Number: 250107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: Required Intervention
• Patient Sex: Unknown