MAUDE Adverse Event Report: NAVILYST MEDICAL, INC. SMART PORT CT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number CT80STPD-VI

Patient Problems Fever (1858); Chills (2191)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

Patient with portacath placed for chemotherapy.Almost two months later, the port would not flush or give blood return.A port flow study conducted revelated the catheter present on the left side with the tip in the superior vena cava (scv).Injection noted leakage of contrast along the subclavian venous region consistent with disruption of the catheter tubing.No contrast extended into the distal portion of the catheter into the svc/heart.The patient experienced temperatures of 101.7 fahrenheits with chills four days later and had the port removed the same day.Symptoms subsided and the patient had no further complications.

• Brand Name: SMART PORT CT
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 603 queensbury ave.; queensbury NY 12804
• MDR Report Key: 18354528
• MDR Text Key: 330871685
• Report Number: 18354528
• Device Sequence Number: 1
• Product Code: LJT
• 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: 10/26/2023

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: CT80STPD-VI
• Device Lot Number: A2023006
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White