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

Model Number	1808060
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Migration (4003)
Health Effect - Clinical Codes	Chest Pain (1776); Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following a successful bard tunneled chest port insertion, approximately two weeks later, the patient returned to emergency room (er) complaining of chest pain.Chest imaging showed catheter portion of chest port broke off/detached and the tip migrated from superior vena cava (svc) to right distal atrium/ventricular junction.Bard representative was notified, awaiting pick up.Remaining 15 chest ports with the same lot number were pulled out from use.Manufacturer response for port-a-cath, implantable powerport 8 fr (per site reporter).Pending review.

• Brand Name: POWERPORT ISP M.R.I. 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: 16350705
• Report Number: 16350705
• Device Sequence Number: 6551096
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/03/2023
• Report Date (Section F): 02/03/2023

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: 1808060
• Device Catalogue Number: 1808060
• Device Lot Number: REGW2769
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• 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: Female
• Patient Weight: 55 KG
• Date Report Sent to FDA: 02/03/2023