MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SMARTPORT CT WITH VORTEX TECHNOLOGY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number H787CT96STSDVI1

Device Problems Material Fragmentation (1261); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Angiodynamics smartport placed on (b)(6) 2021.A routine chest ct on (b)(6) 2021 found contiguous but fragmented metallic foci within the right ventricle adherent to the wall at the level of the mid interventricular septum (series 6, image 127) and at the inferior aspect of the interventricular septum (series 6, image 106).This was not present on (b)(6) 2021.The port was removed on (b)(6) 2022, the fragments will be intentionally retained due to risk of removal.Fda safety report id # (b)(4).

• Brand Name: SMARTPORT CT WITH VORTEX TECHNOLOGY
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 13757299
• MDR Text Key: 287250622
• Report Number: MW5108104
• Device Sequence Number: 1
• Product Code: LJT
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H787CT96STSDVI1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White