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

Model Number	GR3506
Medical Device Problem Codes	Difficult to Insert (1316); Peeled/Delaminated (1454); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the reported information.The procedure performed was a pacemaker implant.The vascular surgeon obtained access into vein via needle; however, was unable to advance the starter wire.The surgeon switched to a glidewire and was able to advance with some repositioning.The procedure continued and leads were positioned.No sine was done until end of case.Artifact was noted on the screen.Upon inspection by interventional cardiologist, it was noticed that the distal end of the glidewire had some type of deformation.It was believed that during repositioning of the glidewire through the needle damage may have occurred.The wire was discarded and the patient was sent to have computerized tomography (ct) and then to interventional radiology (ir) to try and snare the piece of wire.However, the location of the piece of wire and pacemaker leads made it unsafe to try.Ir believed the piece of wire was in a safe place within the pulmonary vein and will reendothelialize.Additional information was received on 29oct2025: the object measures roughly 10cm in length, as measured on imaging by the physician, which was consistent with the length of the distal glidewire section that the interventional cardiologist stated was deformed prior to the wire being discarded accidentally.Additional information was received on 31oct2025: the patient was then placed in a deep trendelenburg.A solitary puncture of the left subclavian was then undertaken and was exchanged for the wire however, the wire kept going up the internal jugular (ij).The patient was placed in a normal position, and it was confirmed that to be the case.The wire was attempted to be moved three times into the subclavian with no success.An angled glidewire with a torque was requested and the user was able to move it down into the subclavian though the wire wanted to go over to the contralateral side.It was then redirected down into the heart.As the user moved into the heart, they saw a slight opacification that had not been there before, and the wire seemed to become longer.They attempted to pull the wire back; however, the opacification did not come back with this.The wire was exchanged with the dilator alone.The short j-wire and the leads that had been previously fashioned were then inserted.The glidewire the tip was then examined was completely intact in 360 degrees.As the user passed their hand, they could feel a very slight defect, perhaps even less than half a millimeter.At 5 cm length it appeared that a portion of the plastic covering of the wire had been sheared free.The user reexamined the dilator it was normal in its appearance.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: director, cardiac cath lab.The actual device has been returned for evaluation.Provided image: although details of the procedure, etc., could not be read from the attached image, it was thought, based on the complaint, that the actual device was fractured in the body and the fragment was left in the body.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.Although details of the procedure, etc.Could not be read from the attached image, it was thought, based on the complaint, that the actual device was fractured in the body and the fragment was left in the body.However, since the actual device was not returned and the investigation of it could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory assures product quality by performing the following inspection and control.Before the product packaging process, 100% visual inspection is performed to ensure there is no anomaly such as peeling of the outer layer or abrasion in appearance.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 substances on the surface of guidewire.The instructions for use (ifu) has the following description: "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.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." please refer to section h10 for the related reports.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: 23573671
• Report Number: 9681834-2025-00216
• Device Sequence Number: 10272771
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: (01)04987350773159(17)260430(10)240524
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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 Expiration Date: 04/30/2026
• Device Model Number: GR3506
• Device Catalogue Number: RF*GA35153A
• Device Lot Number: 240524
• 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: 10/27/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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; Required Intervention
• Patient Sex: Unknown