MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SMARTPORT CT/TI/POLY 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	CT80STPA
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 1:10 pm by risk, rde - this patient entered the or (operating room) for port removal and insertion of a new port-a-cath.Upon removal of the existing port, port was intact and catheter tip was torn upon examination.Port and catheter saved.Patient was transferred to amarillo for removal of broken piece.

• Brand Name: SMARTPORT CT/TI/POLY 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 16364341
• Report Number: MW5114884
• Device Sequence Number: 18103780
• Product Code: LLD
• UDI-Device Identifier: H787CT80STPA0
• UDI-Public: H787CT80STPA0
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: CT80STPA
• Device Lot Number: 5658362
• Was Device Available for Evaluation?: No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 141 KG