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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

Angiodynamics' legal department received a summons, from outside counsel, involving a smartport device.On or about (b)(6) 2020, plaintiff underwent placement of the angiodynamics smartport.The device was implanted by (b)(6) for the purpose of ongoing chemotherapy.On or about (b)(6) 2022, plaintiff began to experience symptoms of an infection.She was eventually admitted to (b)(6) for such symptoms.Plaintiff's medical team determined the plaintiff did indeed develop an infection and that the plaintiff's smartport was the cause of infection.Once it was determined that the smartport was the cause of the infection, plaintiff's medical team made the decision to remove the defective device and it was removed on or about (b)(6) 2022, by (b)(6).As a result of having the smartport implanted, the plaintiff reported experiencing significant mental and physical pain and suffering, has undergone additional surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.

Manufacturer Narrative

The customer's reported complaint description of patient infection cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port/catheter device was returned for evaluation.No dhr review was conducted since there was no reported lot number and ship history report lot review was not performed since item number is also unknown.Similarly, no review of sterilization load release records could be performed since lot number is unknown.Labeling review: the directions for use (dfu) item number 16658102-01 that is provided in the port kit contains the following directions and precautions: contraindications · catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Warnings: · the device is to be implanted, used, maintained, and removed in strict accordance with institutional and or centers for disease control (cdc) guidelines or policies.· reuse of single-use devices creates a potential risk of patient or user infections.Contamination of the device may lead to injury, illness or death of the patient.· do not use syringes smaller than 10 ml syringe when accessing the port as system damage can occur.Flushing occluded catheters with small syringes can create excessive pressures within the port system.Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.· a blood return should be present prior to usage of device for any therapy or testing.· do not attempt to measure the patient's blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.· if the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Precautions · carefully read and follow all instructions prior to use.· strict aseptic technique is of paramount importance when implanting any device.Potential complications use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: erosion of vessel and skin implant rejection infection necrosis of scarring of skin over implant area vessel trauma post-operative care the incision site should be monitored for signs of infection, inflammation, hematoma, device rotation or erosion.Routine wound care should be given to these sites.The smart port ct implantable port may be used immediately after verification of catheter placement.Instruct patient to avoid any heavy exertion or strenuous activity during the first few days after surgery.General guidelines · each access of an angiodynamics smart port ct implantable port should be performed using aseptic technique.· follow institutional universal precautions.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference pr(b)(4).

• Brand Name: SMARTPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 18747286
• MDR Text Key: 335870916
• Report Number: 1317056-2024-00027
• 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: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female