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

Model Number	1778000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with carcinoma of the esophagus and neoplasm of the brain and spinal cord had a single lumen tunneled port placed for chemo in [redacted date].An incision was made in interventional radiology at the upper chest, a pocket was created.An 8f bard powerport (groshong distal valved) silicone catheter with pressure injectable titanium port was inserted into the pocket and the catheter was advanced via a peel-away sheath into the vein under fluoroscopic guidance.Catheter tip position: right atrium was confirmed.The port was sutured into the pocket using absorbable suture.An incidental finding on chest ct [redacted date] noted a fractured port catheter in the svc, extending into the right ventricle.The device was removed in ir the next day.Hardware was sent to pathology.No harm to the patient was apparent.Manufacturer response for powerport implantable port, powerport implantable port (per site reporter), pending device review.

• Brand Name: POWERPORT IMPLANTABLE PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 18501983
• Report Number: 18501983
• Device Sequence Number: 14487010
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/02/2024
• Report Date (Section F): 01/03/2024

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: 1778000
• Device Catalogue Number: 1778000
• Device Lot Number: REEV2838
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• 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
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 01/03/2024