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

Model Number	CT75STSD
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was scheduled to have mediport injection because port was not drawing blood.Once the portagram was done, it was found that the mediport was fractured with the catheter tip in the right atrium/right ventricle.The patient then had to have a procedure in the radiology department to remove the catheter tip.The catheter tip was saved for failure analysis.The mediport will be removed at an unknown future date.

• Brand Name: SMART PORT CT
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9151665
• Report Number: 9151665
• Device Sequence Number: 2547308
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: +H787CT75STSD0
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2019
• Report Date (Section F): 09/06/2019

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: No Information
• Device Model Number: CT75STSD
• Device Lot Number: 5389994
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90
• Date Report Sent to FDA: 09/06/2019