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

Model Number	H787CT96STSDVI1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cardiac Arrest (1762); Muscle Weakness/Atrophy (1967); Shock (2072); Malaise (2359); Bacteremia (4846)
Date of Event	02/19/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The 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).
Event or Problem Description
On or about on (b)(6) 2024, decedent, underwent placement of an angiodynamics smartport product, reference number: h787ct96stsdvi1, and lot number: a2823026.The device was implanted at (b)(6).Decedent's port system subsequently became infected and the catheter portion of the device fractured and embolized.Due to these complications decedent suffered substantial harm and required extensive medical care but ultimately died on (b)(6) 2024.Decedent's pre-death injuries included but were not limited to: infection, shock, multiple surgical procedures, bacteremia, weakness, malaise, and cardiac arrest.She was admitted at (b)(6) from on (b)(6) 2024, and on (b)(6) 2024.She was pronounced dead at (b)(6).
Additional Manufacturer Narrative
The customer's reported complaint description of catheter tubing fractured and detached during in situ treatment/use cannot be confirmed.No port/catheter tubing device was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this catheter detached incident.It was reported that the catheter tubing was fractured and detached within 33 days of the port implant procedure.The customer's reported complaint description of patient infection cannot be confirmed given the patient centric nature of this serious adverse event (sae).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.Sterilization load release records were reviewed for the packaging lot in question; no issues were observed.There have been no other reported complaints for the indicated packaging/catheter lots for similar catheter detached or patient infection issue.The port was implanted into the patient 33 days 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 33 days 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: 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; 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.The following statements reference making the catheter connection to the port housing: insert catheter into sheath.Position the distal end of the catheter at the desired location.Peel away sheath while withdrawing it from vessel.Care should be taken not to withdraw catheter as sheath is removed.Catheter position should be confirmed radiographically.Secure catheter in place.Trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.Slide the blue strain relief mechanism over the end of the catheter.The tapered end of the blue strain relief mechanism should point away from the proximal end of the catheter.For optimal results, the proximal end of the catheter should be dry.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the strain relief mechanism over the catheter and onto the stem until it contacts the port body.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.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.Reference (b)(4).

• Brand Name: SMART PORT CT
• Common Device Name: 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 ; 603 queensbury avenue; queensbury, NY 12804
• MDR Report Key: 24848940
• Report Number: 1319211-2026-00099
• Device Sequence Number: 5624506
• Product Code: LJT
• UDI-Device Identifier: 15051684018197
• UDI-Public: 15051684018197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/08/2026

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: 06/30/2026
• Device Model Number: H787CT96STSDVI1
• Device Catalogue Number: CT96STSD-VI
• Device Lot Number: A2823026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Death; Hospitalization; Life Threatening; Other
• Patient Sex: Female