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

Model Number	GR3506
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Ischemia Stroke (4418)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received reported information indicating that during a cerebral angiogram procedure, the distal tip of a radifocus tc-wire v guidewire sheared off and could not be retrieved due to its location.The procedure was performed to address right cervical internal carotid artery (ica) stenosis, basilar stenosis, and bilateral intracranial atherosclerotic disease.The guidewire was passed through a merit marquis stopcock.A new guidewire was opened, and the procedure was completed without further issues.A neurological evaluation was performed post-procedure, and the patient was reported to be neurologically intact.Minimal blood loss was reported.The procedure performed was a cerebral angiogram.The patient had a medical history that included factor v leiden, hypertension (htn), diabetes mellitus (dm), and was taking daily aspirin at a dose of 325 milligrams (mg).The patient presented with acute right leg weakness and right facial droop and received tenecteplase (tnk), which resulted in symptom improvement.Relevant imaging included computed tomography angiography (cta), which demonstrated right cervical internal carotid artery (ica) stenosis, basilar stenosis, and bilateral intracranial atherosclerotic disease.Magnetic resonance imaging (mri) revealed a small infarct in the left cerebellar region and the left precentral gyrus.Additional information received on 15 aug 2025 indicated that the patient was stable with no neurological deficits.The sample was not contaminated.Additional information received on 26 aug 2025 stated that the physician had reached out multiple times regarding this product performance report (ppr) to determine whether the patient could safely undergo magnetic resonance imaging (mri) in the future.Although the patient was currently stable, the physician was seeking confirmation due to uncertainty about the presence of metal in the retained wire fragment.The sample was mailed back along with another wire from the same box.Additional information received on 29 aug 2025 from ashitaka indicated that approximately 4 millimeters (mm) of urethane were missing from the tip of the sample.A precise cutting mark was observed on the surface of the core wire, suggesting that the core wire itself was not damaged.However, since the guidewire is composed of magnetic material, the possibility of heat generation during mri or movement of the broken fragment within the body cannot be ruled out.Therefore, the use of mri is not recommended.

• 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
• MDR Report Key: 23034720
• Report Number: 2243441-2025-00049
• Device Sequence Number: 15873646
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: (01)04987350773159(17)261231(10)250108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2025
• Report Date (Section F): 09/11/2025

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: GR3506
• Device Catalogue Number: RF*GA35153A
• Device Lot Number: 250108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035'' 150CM GLIDEWIRE REGULAR.; 5FR GLIDESHEATH SLENDER.; SIM 2 GLIDECATH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 09/11/2025