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

Model Number CG412

Patient Problem Foreign Body In Patient (2687)

Event Date 03/27/2024

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 19201354
• MDR Text Key: 341263844
• Report Number: 19201354
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: (01)04987350772138(17)250930(10)221017
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 04/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male