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

Model Number	CG412
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of peripheral arterial disease and recent gangrene of bilateral lower extremities.Procedure: aortogram and angioplasty of the left common iliac artery and external iliac artery with a 6 mm x 100 mm drug-coated balloon, and angioplasty of the common femoral artery and superficial femoral artery with a 6 mm x 6 cm drug-coated balloon and mynx.Catheter broke into 2 pieces inside the patient.Surgeon successfully retrieved both pieces without known injury.Patient discharged the same day.

• Brand Name: GLIDECATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 19201354
• Report Number: 19201354
• Device Sequence Number: 8143197
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: (01)04987350772138(17)250930(10)221017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/11/2024
• Report Date (Section F): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CG412
• Device Catalogue Number: RF*ZM7410GA
• Device Lot Number: 221017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 04/11/2024