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

Model Number	H787CT66PTPD0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's reported complaint description of patient thrombosis 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 in situ use/treatment.Thrombosis is cautioned in the device directions for use (dfu) as potential complication for an implanted port system.A device history record (dhr) review of the indicated packaging lot 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.Labeling review: the directions for use (dfu) that is supplied with this port device contains the following statements: warnings: - 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.- if the patient complains of pain, or if 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: · 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: these complications are well documented in literature and should be considered when a venous access device is utilized.Air embolism, catheter malposition, clot formation, fibrin sheath, infection, inflammation, thromboembolism, thrombophlebitis, thrombosis.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).
Event or Problem Description
On or about on (b)(6) 2013, plaintiff underwent placement of an angiodynamics smartport ct port catheter product, with model number: ct66ptpd, and lot number: 602766.This smartport devices consisted of a port body and a polyurethane catheter.The smartport device was implanted via the right internal jugular vein by dr.(b)(6), m.D., at the (b)(6), for the purpose of ongoing chemotherapy treatment.On or about on (b)(6) 2014, plaintiff presented to the (b)(6) in (b)(6), with complaints of a malfunctioning port.A venous ultrasound was performed for evaluation of a potential thrombosis.The ultrasound identified a near occlusive thrombus within the internal jugular vein and proximal subclavian vein, which required the port to be removed.Due to the ongoing need for venous access, a decision was made by plaintiff's physicians to leave the port in place until treatment was completed.On or about on (b)(6) 2014, plaintiff underwent removal of the smartport.The procedure was performed by dr.(b)(6), m.D., at the (b)(6) in (b)(6).

• 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: 25480892
• Report Number: 1319211-2026-00202
• Device Sequence Number: 9735320
• Product Code: LJT
• UDI-Device Identifier: 15051684017985
• UDI-Public: 15051684017985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• 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): 06/11/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: H787CT66PTPD0
• Device Catalogue Number: CT66PTPD
• Device Lot Number: 602766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention; Other; Life Threatening
• Patient Sex: Male