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

Model Number	H787CT75STSD0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2012, the plaintiff underwent placement of the following: angiodynamics' "smart port", identified by the following: catalog number: ct75stsd, lot number: 569291 for the purposes of the plaintiffs continued medical treatment.On or about (b)(6) 2021, the device at was implanted by dr.(b)(6) at (b)(6) for the purposes indicated above.Thereafter, the plaintiff developed multiple infections as diagnosed by her health care providers.The plaintiff received medical care and treatment for the above medical conditions.Further, the plaintiffs smart port catheter fractured, and pieces of the catheter did become lodged in her veinous system and her heart.As a result, the plaintiff required medical care and treatment and underwent multiple surgeries to remove fragments of the fractured catheter.On or about (b)(6) 2022, the plaintiff underwent surgery for removal of retained intra vascular catheter from her superior vena cava, a patch angioplasty of the superior vena cava with native vena cava utilizing cardiopulmonary bypass, at the (b)(6).
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.Without receiving product for evaluation the root cause of the reported catheter detached cannot be determined.A device history record (dhr) review of the indicated packaging/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Certificate of conformance for the sterilization process for the reported packaging lot was verified to be approved at time of distribution.The port was implanted into the patient for more than 9 years prior to the patient's infection.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 9 years later.Device directions for use (dfu) 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 with the port device contains the following statements: 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.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.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.Precautions · carefully read and follow all instructions prior to use.· strict aseptic technique is of paramount importance when implanting any device.· for peripheral placement, irritation to the vein, resulting in postoperative thrombophlebitis, has been associated with guidewire and introducer insertion.· when using percutaneous introducers: to avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator.· if more than one drug is to be administered, between the individual drug applications, flush the system with 5 to 10 ml normal saline for injection to prevent drug interactions.· after any infusion, injection or bolus application, the system should be flushed with normal saline for injection or locked with a heparin solution per institutional protocol to prevent thrombotic occlusion of the catheter.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: air embolism catheter disconnection or migration catheter embolization catheter fragmentation catheter pinch-off clot formation drug extravasation (leakage) erosion of vessel and skin implant rejection infection a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint continues to be monitored for trends.(b)(4).Inflammation thromboembolism thrombophlebitis thrombosis necrosis of scarring of skin over implant area.Vessel trauma catheter placement considerations: warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.Pinch-off syndrome pinch-off syndrome signs may include difficulty in aspirating blood, resistance to flushing or infusion of medications or fluids that improves with position changes, infraclavicular pain and/or swelling with catheter flushing or infusion palpitations, sudden onset chest pain, cardiac arrhythmias, extra heart sound, chest wall swelling at the port pocket, vein insertion site, pain in shoulder or port area not associated with swelling, cough, paresthesia of arm on side of catheter withdrawal occlusion or swishing sound with catheter flushing.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.

• 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: 22897240
• Report Number: 1317056-2025-00220
• Device Sequence Number: 5916633
• Product Code: LJT
• UDI-Device Identifier: 15051684018005
• UDI-Public: 15051684018005
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: H787CT75STSD0
• Device Catalogue Number: CT75STSD
• Device Lot Number: 569291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Female