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

Model Number	CG412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the 4fr glidecath was placed up and over the aortic bifurcation contralaterally from the left side.While pulling the catheter back across the bifurcation the catheter tore with approximately 30% of the catheter lodging itself in the right common iliac.The right groin was accessed, and the broken piece of catheter was snared and safely removed.The physician stated that the patients' vessels were calcified.The were no blood loss.The patient condition was stable.The procedure was an aorta bilateral femoral angiogram.Additional information was received on 18apr2025: the doctor believed the patients calcification had something to do with the issue.

• 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: 22024886
• Report Number: 2243441-2025-00017
• Device Sequence Number: 9114183
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: (01)04987350772138(17)250831(10)220915
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/14/2025
• Report Date (Section F): 05/14/2025

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 Expiration Date: 08/31/2025
• Device Model Number: CG412
• Device Catalogue Number: RF*ZM7410GA
• Device Lot Number: 220915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2025
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• 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: 05/14/2025