MAUDE Adverse Event Report: Terumo Corporation, Ashitaka GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GR1805
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: it was reported that a 72-year-old male was undergoing a cardiac device implantation procedure when a 0.018-inch guidewire became trapped beneath the left clavicle and could not be removed through the sheath.A ct scan indicated the wire was located superficially in the subcutaneous tissue.The patient was brought back to the electrophysiology lab, prepped and draped in standard fashion.Fluoroscopy was used to mark the location of the wire.This wire was not attached to anything in the heart and was essentially entrapped behind the clavicle, likely in the fascia.An incision was made over the sternoclavicular joint, and the dissection was carried down into the subcutaneous tissue over the head of the clavicle.Without entering the left pleural space, we followed the clavicle and located the wire.Lt was grasped with the hemostat and retrieved without difficulty.We then irrigated, making sure there was no bleeding.Satisfied, the wound was closed in a layered fashion with absorbable suture.The patient tolerated the procedure well.There were no unforeseen complications.During advancement of the glidewire through the patient's left subclavian vein, the wire became lodged.When the physician attempted to remove the device, the glidewire fractured approximately 10 to 11 inches from the distal tip.A portion of the fractured wire remained within the patient and could not be retrieved initially.Following consultation with the cardiovascular surgery team, the patient was returned to the electrophysiology (ep) lab, where the retained wire fragment was successfully retrieved.Additional info received 01-sept-2026: the patient was evaluated, and a computed tomography (ct) chest with and without contrast was performed on (b)(6) 2026 at 12:11 pm to assess the position of the retained wire fragment in the left subclavian/svc region.Estimated blood loss was minimal.The patient was reported to be stable post-procedure with no complications following retrieval of the retained wire fragment.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomiya, shizuoka 418-0 015; JA 418-0015
• MDR Report Key: 50590719
• Report Number: 2243441-2026-00042
• Device Sequence Number: 9451535
• Product Code: DQX
• UDI-Device Identifier: 04987350772855
• UDI-Public: (01)04987350772855(17)271031(10)251118
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: GR1805
• Device Catalogue Number: GR1805
• Device Lot Number: 251118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 294 LB
• Patient Race: White
• Date Report Sent to FDA: 09/03/2026