MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDECATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	CG416
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: during an angiogram with interventions, the glidecath broke off into the patient.The doctor was able to recover the broken piece from the patient.Additional information was received on 09oct2025: the vessels throughout the aortoiliac and femoral-popliteal area were extremely atherosclerotic and diseased.There was a high-grade focal stenosis in the mid right common iliac.The glidecath broke inside the patient during access.The broken piece was recovered.The distal iliac vessels were patent.The common femoral was heavily diseased but patent.The superficial femoral artery (sfa) occluded proximally with dense calcified plaque throughout into the above-knee popliteal.The below-knee popliteal was patent with two-vessel runoff into the foot.Surgeon unable to cross the right superficial femoral artery (sfa) occlusion however, they did get good angiographic result after treatment of the right common iliac with return of a strong right femoral pulse.The estimated blood loss was less than 250cc.Additional information was received on 10oct2025: there was no impact on the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no 1 to correct sections b4 and f11 as they had the incorrect date in the inital report.Please refer to those sections for the correct date that should have been inputted on the initial report.

• Brand Name: GLIDECATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 23478045
• Report Number: 2243441-2025-00062
• Device Sequence Number: 10526582
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: (01)04987350772213(17)271031(10)241129
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025
• Report Date (Section F): 10/31/2025

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: CG416
• Device Catalogue Number: RF*ZV94110A
• Device Lot Number: 241129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/31/2025