MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SMART PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Lot Number 5344485

Device Problems Fracture (1260); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  Injury  

Event Description

On (b)(6) 2019 patient had a smart port implant placed for chemotherapy use.On (b)(6) 2021 this device was removed due to a kink and fracture in the catheter which found during a port study.The port was deemed unusable nor salvageable by endovascular procedure and recommended to be removed by provider.On (b)(6) 2021 port was removed by provider and new port replaced.Port a cath implant.Fda safety report id# (b)(4).

• Brand Name: SMART PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 12336777
• MDR Text Key: 267270408
• Report Number: MW5103302
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 5344485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR