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	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor was doing a leg intervention and was trying to get up and over with a long 5fr x 45cm sheath.The bifurcation was very steep, so he advanced a amplatz wire over and took dilator out.He put the cg416 in and tried to advance down the contralateral side.There was a lot of calcifications on the contra iliac side and when he pulled the glidecath back it broke off in the patient.He snared the piece and there were no complications.The patient was stable.There was no blood loss.Additional information was received on 05mar2025: testing was performed to verify the piece was removed entirely.

• 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: 21692846
• Report Number: 2243441-2025-00006
• Device Sequence Number: 21140688
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: (01)04987350772213(17)270228(10)240311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/25/2025
• Report Date (Section F): 03/25/2025

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: 240311
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2025
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• 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: 5FR X 45CM SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/25/2025