MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT CT; SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE

Catalog Number CT80STPD

Device Problems Fracture (1260); Migration (4003)

Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A patient reported experiencing an issue with an angiodynamics port.The following was reported via the customer service "contact us now" submission box: "my name is [redacted], i am a receiver of one of your medical ports.During the removal of the port after the cancer was in remission, the tip of your port, broke off and is now inside my heart on the superior vena cava and right ventricle of my heart.I need to speak to someone in the legal depart ment.Or atleast someone in your administrative department.At (b)(6) where im currently undergoing treatment do to some infection that this caused.(b)(6) im in (b)(6) " further follow up determined that the device was explanted in (b)(6) of 2018.The tip fragment has been in situ since this date as it was determined that it would be too risky to remove.Patient has reported experiencing ongoing infections, including endocarditis, as a result of the fragment.Patient was unable to provide brand name, upn or lot number of device.

Manufacturer Narrative

Additional information received: brand name of port.The customer's reported complaint description of patient infection cannot be confirmed given the patient centric nature of this serious adverse event (sae).The reported complaint of catheter tubing tip was detached and retained in the patient could also not be confirmed since no complaint sample was returned.Without receiving a complaint sample for evaluation a definitive root cause for this event could not be determined.A four-year ship history report was performed for account number (b)(4) from 01-jan-2014 to 01-jan-2018 to cover any port upn shipped to this account that would not be expired in all of 2017.Review of this shr shows that only one port upn ((b)(6), smartport) was shipped to this customer in this four-year time period.Affected items tab updated with this upn, lot number is still unknown.In lieu of a reported lot number, the ship history report (shr) was reviewed for item number ((b)(6)) in order to ascertain all shipments in 2017.The lot(s) obtained through the shr are: 5116069, 5126587, 5128735, 5131142, 5148498, 5196614 and 5196911.Each lot number had one port item shipped for a total of 7 ports shipped in 2017.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu) that is provided in the port kit 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: · 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.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.· 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: to avert device damage and/or patient injury during catheter placement: · avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.· use only smooth-edged atraumatic clamps or forceps.· do not use the catheter if there is any evidence of mechanical damage or leaking.· avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.· carefully follow the catheter to port connection technique provided in the dfu to ensure proper device connection and to avoid catheter damage.· assure tight connection between port body and catheter.· after implantation or any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol.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.Infection.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
• Type of Device: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17907089
• MDR Text Key: 325342202
• Report Number: 1317056-2023-00137
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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
• Device Catalogue Number: CT80STPD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 113 KG