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

Model Number H787CT80STPDVI1

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  Injury  

Event Description

We have concluded that this incident involved a possible design flaw of the connector to the port.As described by the surgeon, he feels that the blue connector was not a snug fit at the time of implantation and at the time of removal at the bedside the catheter slipped through the blue connector and remained within the subcutaneous tissue.The physician indicated there are three pieces to the port (the port, the connector, and the catheter/tip), the surgeon stated he thought upon removal, all pieces were intact.The blue connector was found when the patient underwent a pet scan.Once this was reported to the surgeon, the patient was taken to the operating room on (b)(6) 2020 for removal of the blue connector, which was found within the subcutaneous tissue.Fda safety report id# (b)(4).

• Brand Name: ANGIODYNAMICS SMART PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 10945685
• MDR Text Key: 219878320
• Report Number: MW5098194
• 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: Dentist
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H787CT80STPDVI1
• Device Lot Number: 5536691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 35 YR