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

Model Number	H787CT96STSD0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
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 (b)(6) 2016, plaintiff underwent right internal jugular placement of an angiodynamics smartport port catheter product, model number h787ct96stsd0, lot number 5078406.The smartport was implanted by dr.(b)(6), m.D, (b)(6) medical center in (b)(6).On or about (b)(6) 2018, plaintiff presented to (b)(6) medical center for an infusion.During the infusion, plaintiff experienced neck swelling and underwent a port study.The study demonstrated extravasation of contrast around the neck area.The defective device was replaced with an angiodynamics smartport catheter product, by dr.(b)(6), m.D.
Additional Manufacturer Narrative
The customer's reported complaint description of a piece of the port broke off of the device during the port explant procedure and is still in the patient's chest could not be confirmed given the patient centric nature of this event.The specific portion of the device that broke off and where it is located was not provided, despite good faith efforts.Potential failure mode is catheter tubing fracture/detachment due to adherence to vasculature wall/fibrin sheath.Angiodynamics cannot provide guidance regarding mri safety without understanding the details that occurred in the port explant procedure.The dfu for the smartport device does discuss mri conditional 3t, see labeling review section.There was no report of port system malfunction or performance issue during device use (in situ).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 incident.Device history record review of the packaging/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the directions for use (dfu) that is supplied 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.Warnings: do not use syringes smaller than 10 ml when accessing the port as system damage can occur.Flushing occluded catheters with small syringes can create excessive pressures within the port system.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.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 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.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: catheter disconnection or migration, catheter embolization, catheter fragmentation, catheter pinch-off, drug extravasation (leakage).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.Mri conditional 3t.For all angiodynamics smart port® ct family of ports, the term mri conditional is applied.The devices are tested in accordance with the astm standard for mri sensitivity.The exact meaning is as follows: non-clinical testing has demonstrated the device is mr conditional.It can be scanned safely under: static magnetic field of 3 tesla or less, spatial gradient field of 720 gauss/cm or less, maximum specific absorption rate (sar) of 3 w/kg for 15 minutes of scanning.In non-clinical testing, the device produced a temperature rise of less than 0.7°c at a maximum specific absorption rate (sar) of 3 w/kg for 15 minutes of mr scanning in a field (field strength 3 tesla)(model excite)(manufacturer ge)(software version g3.0-052b) mr scanner.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; 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: 21592298
• Report Number: 1317056-2025-00065
• Device Sequence Number: 14143171
• Product Code: LJT
• UDI-Device Identifier: 15051684018067
• UDI-Public: 15051684018067
• 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: 2016
• Device Explanted Year: 2018
• 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): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: H787CT96STSD0
• Device Lot Number: 5078406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female