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

Model Number	CG415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while inserted in the aorta, 15cm's of the tip broke off in the patient and it took an hour for it to be retrieved.Additional information was received on (b)(6) 2025: the procedure performed was an aortogram, right leg angiogram, left iliac angioplasty, and retrieval intravascular device.Additional information was received on (b)(6) 2025: the patient was stable and went home the same day.Catheter broke off while crossing an iliac stenosis getting into the abdominal aorta for an angiogram.Blood loss was minimal.A stiff amplatz wire was through the catheter at the time it snapped off.It was retrieved with a snare catheter.

• Brand Name: GLIDECATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 21521098
• Report Number: 2243441-2025-00005
• Device Sequence Number: 20946023
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: (01)04987350772190(17)270228(10)240304
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/04/2025
• Report Date (Section F): 03/04/2025

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: CG415
• Device Catalogue Number: RF*ZV9410GA
• Device Lot Number: 240304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2025
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• 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: ALBUTEROL INHALER.; AMPLATZ WIRE.; ATORVASTATIN 80MG.; JARDIANCE.; LOPRESSOR 50MG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White
• Date Report Sent to FDA: 03/04/2025