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

Model Number CT80STPA

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  Injury  

Event 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
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 16364341
• MDR Text Key: 309507602
• Report Number: MW5114884
• Device Sequence Number: 1
• Product Code: LLD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 141 KG