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

Model Number CG505

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2023

Event Type  Injury  

Event Description

From staff: tavr on [redacted date].On [redacted date] imaging revealed a 9cm retained wire.The plan was to leave in place due to risk of removal.Patient experienced oozing from site and possible infection requiring admission on [redacted date].Removal was discussed; however, patient did not wish to have another surgical procedure.Notified of event by patient's insurance company.It is unclear what device was retained.The devices we are reporting are a possibility of the retained object.The device information provided is from another like device; not the actual device.

• Brand Name: GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 19180840
• MDR Text Key: 341027687
• Report Number: 19180840
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2024,04/04/2024

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?: No
• Device Model Number: CG505
• Device Catalogue Number: RF*XI7510GA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 115 KG