MAUDE Adverse Event Report: ANGIODYNAMICS INC POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number CT80STTD-VI 8F

Device Problem Fracture (1260)

Patient Problems Fever (1858); Hematoma (1884); Chills (2191); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Patient had mediport placed a few months ago in the left subclavian for chemotherapy use with fluoroscopy confirmation of position.A couple of months after it was placed, after therapy administered, edema the port needle was removed.Edema was noted around the port site along with ecchymosis.Patient reported the area was a little tender to the touch, but did not complain of any discomfort during the infusion.Patient was instructed to apply ice to the area when she got home, and to call if symptoms worsen.Same day, the patient completed her last chemotherapy treatment without any difficulty with the port.Port was ordered to be removed prior to radiation therapy.Two days later, patient arrived to the emergency department complaining of fever and chills with recent hematoma of port site.Chest x-ray 1 view showed ¿left chest port in place via the left subclavian vein.Catheter terminates along the cavoartial junction¿.Patient was started on iv antibiotics.Three days after arriving to ed, surgery attempted to remove the mediport at the bedside.However procedure was complicated by finding the ¿port not in continuity with a fractured separation just distal to blue flange¿.Post procedural chest x-ray confirmed ¿the infusion port itself is no longer seen.Most of the catheter remains in place again with the tip projected in the region of the right atrium.¿ patient was taken to the operating room the same day to retrieve the residual catheter found in the infraclavicular space.Blood cultures drawn are negative for growth.Catheter tip cultured was also negative for growth.

• Brand Name: POWERPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS INC; 603 queensbury ave; queensbury NY 12804
• MDR Report Key: 14753945
• MDR Text Key: 294407952
• Report Number: 14753945
• 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: 05/24/2022

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: CT80STTD-VI 8F
• Device Lot Number: 5708020
• 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: 05/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White