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

Model Number CT80STPD

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 07/19/2023

Event Type  malfunction  

Event Description

Patient arrived to the clinic to receive chemotherapy.Patient here for folfox c4 d15.Patient ambulates to infusion suite without assistance.Identity confirmed using two patient identifiers: dob and full name.Labs wnl.Patient seen by provider prior to treatment.Port access by this registered nurse (rn) with sterile techniques as port was flushed with normal saline patient grimaced due to discomfort.Patient repositioned with same results.Charge nurse at chairside to assess port site.Patient again has discomfort with saline being pushed in port.Port de accessed with huber needle intact.Fluid noted coming from port site.Port re accessed.Patient still has discomfort and swelling noted around port site.Port de accessed with huber needle intact.Plan of care explained to patient and questions answered.Patient left in stable condition and sent to radiology department for fluoroscopy.Patient had port removed, deemed to be a malfunctioning port.New port implanted.Patient seen to have a new port implanted after the new port that was previously installed.Patient ambulatory to clinic for c5d15 folfox.Patient identity confirmed using 2 identifiers (name and dob), denies new complaints.Labs and orders reviewed. vs wnl. implanted pac l chest with skin intact; dermabond to the site.Port accessed per protocol using aseptic technique, brisk blood returned, biopatch applied, needle secured with tegaderm dressing.Kvo ;d5 ;initiated via pac and pre-meds administered.20 mins into zofran/decadron infusion, patient started complain of discomfort at the port site.Moderate swelling noted around the port site.Infusion stopped.Dressing removed and port deaccessed.Small amount of clear, blood-tinged fluid expressed from the site.Swelling slightly improved.Port reaccessed using sterile technique by rn.Patient complain of pain when trying to flush with 10cc ns syringe, minimal amount of blood return noted (<1 ml).Port covered with tegaderm and provider notified by nurse.Patient sent to ir for port study.Chemotherapy medications returned to pharmacy.

• Brand Name: SMART PORT CT
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 26 forest st; marlborough MA 01752
• MDR Report Key: 18290915
• MDR Text Key: 330044801
• Report Number: 18290915
• 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: 10/05/2023

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 Model Number: CT80STPD
• Device Lot Number: 5772390
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: Black Or African American