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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the case was a right femoral arterial access with a micro puncture kit and exchange for five french merit vertebral catheter over bentsen wire.The subject wire.035, 180 cm angle glide wire was inserted through a three-way stopcock to advance the catheter to the target site beyond the right carotid artery.The glidewire was removed smoothly without incident.A right cerebral angiogram was obtained.An x-ray artifact found near the area where the glidewire was previously.The patient's hair and x-ray table were inspected in an attempt to locate the external x-ray artifact; however, none was found.An abnormality was noted on the leading edge of glide wire by a tech.The tech noted it looked like a fiber on the leading edge.It was suspected that the tip of the glide wire became separated from the water body and was inside the patient.Additionally, a right cerebral angiogram was obtained.A snaer catheter system was inserted in an attempt to remove the x-ray artifact; however, it was unsuccessful as the artifact became dislodged and traveled into the distal cerebral artery.The x-ray artifact was left in the patient.The catheter and sheath were removed.The patient had previous carotid issues which led to the pipeline placement.The blood loss was less than 250cc's.Additional intervention was required in an attempt to remove the glidewire tip.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 16oct2023: there was no noted difficulty with the wire being advanced as described through the 3-way stopcock.There is no additional intervention planned to remove the wire fragment.The patient was in stable condition and was discharged for the hospital.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18221540
• Report Number: 2243441-2023-00046
• Device Sequence Number: 17560638
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 11/28/2023

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: GR3508
• Device Lot Number: 221026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• 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: 3-WAY STOPCOCK; MERIT VERTEBRAL CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/28/2023