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

Model Number	H965451190
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Male patient had port placed via interventional radiology.He presented to his oncology office the next day for an infusion.Upon flushing the port in prep for his infusion, the patient complained of pain.Due to this, the port was not used.The next day, patient (pt) underwent a venogram, which showed the port catheter had dislodged and migrated to the right atrium.The pt required transfer to another campus and ct surgery consult.Four days after port placement, he underwent successful loop snare retrieval of the catheter, and a new port was placed for his oncology treatment.It is unknown if the port/catheter was faulty or if it wasn¿t connected properly.The port/catheter was not saved for inspection.

• Brand Name: XCELA
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 18474789
• Report Number: 18474789
• Device Sequence Number: 6842975
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2023
• Report Date (Section F): 12/21/2023

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: H965451190
• Device Lot Number: 153231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Date Report Sent to FDA: 12/21/2023