MAUDE Adverse Event Report: BARD VASCULAR / BARD ACCESS SYSTEMS, INC. BARD POWER PORT ISP M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 4808560

Device Problems Material Separation (1562); Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 01/19/2022

Event Type  Injury  

Event Description

Patient had a iv port inserted in her chest on (b)(6) 2018 for treatment of breast cancer.On (b)(6) 2022, the patient presented to hematology/oncology for port access in preparation for mri.The nurse access the port and the patient reported discomfort on the right side of her neck when the line was flushed.The nurse was not able to obtain a blood return.The physician was notified and a stat chest x-ray was done.The x-ray showed: discontinuous right-sided port-a-cath with the proximal tip terminating at the level of the 1st rib, and the distal portion within the heart.The patient was sent immediately to interventional radiology (ir) for removal of the port.The patient underwent 2 procedures in ir: retrieval of port catheter fragment from the right atrium via the femoral vein with ultrasound guidance; removal of the remainder of the port cath.The patient tolerated the procedures well and was discharged to home.Fda safety report id# (b)(4).

• Brand Name: BARD POWER PORT ISP M.R.I. IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD VASCULAR / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13342364
• MDR Text Key: 284473174
• Report Number: MW5106918
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2022

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: 4808560
• Device Catalogue Number: 4808560
• Device Lot Number: RECP2507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White