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	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: the glidecath broke in half in the body.It was still attached to the wire, and they snared it out.Additional information was received on 08oct2025: there was no patient injury and the patient was stable.Additional information was received on 09oct2025: there were no fragments left in the body; it was snared out.

• 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: 23442328
• Report Number: 2243441-2025-00057
• Device Sequence Number: 20068852
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: (01)04987350772190(17)280131(10)250213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• 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: CG415
• Device Catalogue Number: RF*ZV9410GA
• Device Lot Number: 250213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/07/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/31/2025