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 Bacterial Infection (1735); Cardiac Enzyme Elevation (1838)

Event Date 10/08/2023

Event Type  Injury  

Event Description

This event was reported via angiodynamics' contact us email, as follows: "my 38-year-old niece with breast cancer underwent a venous port insertion for chemotherapy.The port implantation team claimed that it was an american brand which was imported from usa.After few weeks she started feeling unwell, severe nausea, vomiting and fever.She was admitted to ccu, then infection ward and finally was diagnosed and treated for pseudomonas aeruginosa infection of the port.More cases of venous access port infection at several hospitals were reported.Retrospective studies are being carried out to evaluate risk factors.Since all patients who developed infection had this type of ports in place, the type of the port might be considered as a contributing factor.She lives in iran and there have been a number of sanctions from many countries against our country especially us, is it possible that these ports were manufactured in another country (or even in iran) and labeled as made in usa? i am attaching documents that were provided to the patient, for your consideration." good faith efforts obtained the following details: "the port was implanted in laleleh hospital located in sima-ye-iran street, phase 5,tehran, iran at october first 2023.According to the patient the port was placed at radiology department, under local anesthesia and fluoroscopic guidance.She was provided with a patient teaching written material and a printed card to be filed by her.Her chemo was scheduled for one week after port implantation, but was postponed because she was feeling flue like symptoms.Her chemotherapy course was completed after six weeks.She was feeling tiredness, fever, nausea and vomiting during that time, which doctors and nurses attributed it to chemo complication.She was given acetaminophen for fever, which helped but, chilling and vomiting came back and she was admitted to ccu in laleh hospital due to increased cardiac enzymes.One week after completing chemotherapy she went to hospital for irrigation and she experienced chilling, vomiting and high fever.She was admitted to infectious ward.Samples of urine, blood and port were taken.The port culture was positive for pseudomonas aeruginosa.She was treated with intravenous levofloxacin.The port was removed on january 8 2024.The port was sent to laboratory and is not available.Her treatment was successful and she discharged from the hospital.".

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 since there was no report of port malfunction or performance issue.No device history record (dhr) review was conducted since there was no reported lot number and ship history report (shr) lot review was not performed since upn/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) 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 (b)(4).

• Brand Name: SMARTPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18875978
• MDR Text Key: 337339586
• Report Number: 1317056-2024-00048
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

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: 02/16/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female