MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1878000
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Material Fragmentation (1261); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bard power port was placed (b)(6) 2025 in left chest site in preparation for chemotherapy with good placement per imaging.(b)(6) 2025-when first dose of chemotherapy began, patient had burning, pain sensation and swelling site of power port.Port study imaging showed port catheter was fractured with migration of distal fragment into the right atrium/right ventricle of the patient's heart.Patient was asymptomatic with catheter fracture itself and was transferred to higher level of care for interventional radiology consult where a vascular interventional radiology procedure was completed to remove the migrated fragment with no complication.A new port catheter was placed the next day by vascular interventional radiology in another procedure and patient remained without symptoms or complications.She was discharged the next day to home.No cardiology workup needed post discharge.

• Brand Name: BARD POWER PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 22338575
• Report Number: MW5171963
• Device Sequence Number: 17132826
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 1878000
• Device Lot Number: REJZ0644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White