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

Model Number	CT80STPD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768); Swelling/ Edema (4577)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2022, plaintiff underwent placement of the angiodynamics smartport, model number: h7887ct80stpd0 and lot number: 5715892.The device was implanted by dr.(b)(6) m.D., at (b)(6) hospital in (b)(6) for chemotherapy treatment.On or about (b)(6) 2022, plaintiff experienced pain and swelling at the port site and underwent a thrombosis workup at (b)(6) hospital.A doppler study indicated that plaintiff was not experiencing a deep venous thrombosis; however, fluid was observed along the medial margin of the port.On or about (b)(6) 2022, plaintiff underwent a port study at (b)(6) hospital after being diagnosed with cellulitis.The study revealed significant subcutaneous edema.On or about (b)(6) 2022, plaintiff presented to (b)(6) hospital for port removal due to a port site infection.Plaintiff's medical team determined that the smartport was the source of the infection and required removal.Cultures from the catheter tip tested positive for staphylococcus epidermidis.The defective device was removed by dr.(b)(6), m.D.As a result of having the smartport implanted, plaintiff has, allegedly, experienced 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.
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional 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 device was returned for evaluation since there was no report of port device malfunction, damage or performance issue during use.A device history record (dhr) review of the indicated packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Sterilization load release records were reviewed for the packaging lot in question; no issues were observed.The port was implanted into the patient more than 7 months prior to the patient's infection.There was no report of port device malfunction or performance issue during use.If the manufacturing/packaging/sterilization of the port device in question was to contribute to an infection in the patient it would have likely occurred shortly after the implant date and not more than 7 months later.Device direction for use cautions that each access of the port should be performed using aseptic technique, following the institutions universal precautions.There is no indication from the reported complaint that the manufacturing/packaging/sterilization of the port device could have contributed to the patient's infection.Infection is cautioned in the device dfu as a potential complication of port system use.Labeling review: the directions for use (dfu) that is provided in the smartport device 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: SMART PORT CT
• Common Device Name: 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: 21180675
• Report Number: 1317056-2024-00316
• Device Sequence Number: 4262270
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: CT80STPD
• Device Lot Number: 5715892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/05/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Female