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

Model Number	GS3506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a vascular procedure in ir, the tip of the stiff angled glidewire broke off in a collateral vessel.The tip could not be retrieved before the end of the procedure.There was no blood loss reported.The injury involved the tip of the glidewire breaking off and being left inside a collateral artery.No direct allegation has been made.Pre-procedure condition: the patient presented with prolonged bleeding during dialysis treatments.An angiogram confirmed a total cephalic arch occlusion.Additional information was received on 3 sept 2024: there was no harm to the patient's vessel.The physician attempted to cross a total occlusion in the patient's cephalic arch.Although the occlusion was not crossed, no harm was caused.The tip was left in the stenosis as it is in a stable position with little risk of migration.The patient is stable and experienced no adverse effects from the event.The sample was in the body and in contact with blood but was wiped off before collection.It is not contaminated by infectious agents or anti-cancer agents.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20312966
• Report Number: 2243441-2024-00027
• Device Sequence Number: 7782560
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: (01)04987350773593(17)251130(10)231204
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/26/2024
• Report Date (Section F): 09/26/2024

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: 11/30/2025
• Device Model Number: GS3506
• Device Catalogue Number: RF*PA35153A
• Device Lot Number: 231204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/26/2024