MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; SMART PORT CT LOW PROFILE TITANIUM PORT SYSTEM

Catalog Number CT66LTPD

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Arrhythmia (1721); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).

Event Description

Angiodynamics' legal department received a summons involving a ct low profile titanium 6.6fr w/poly cath.On or about on (b)(6) 2022, plaintiff underwent placement of an angiodynamics smartport, for the purpose of chemotherapy treatment.On or about on (b)(6) 2022, the device fractured, causing severe injury to the plaintiff.On or about on (b)(6) 2022, the plaintiff underwent surgery with surgical associates of (b)(6) at (b)(6) to remove the port and fractured catheter.As a result of having the smartport implanted, the plaintiff reported experiencing significant mental and physical pain and suffering, and will undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, and present and future lost wages.The injuries, conditions, and complications suffered include but are not limited to hemorrhage; cardiac/ pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction.

Manufacturer Narrative

The customer's reported complaint description of port catheter fractured and detached cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history record review of the packaging, assembly and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no ncr's written against the indicated lots.In addition, there have been no ncr's written against catheter item number 107482 for any product non-conformance issue in the past 15 months.Labeling review: the directions for use (dfu) item number 14600330-01 that is provided in the reported 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.· do not forcefully flush the port system with any syringe size.After confirmation of patency by detecting no resistance and the presence of a blood return, use syringes appropriately sized for the medication being injected.Do not transfer the medication to a larger syringe.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.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 pr(b)(4).

• Brand Name: SMART PORT
• Type of Device: SMART PORT CT LOW PROFILE TITANIUM PORT SYSTEM
• 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: 18348060
• MDR Text Key: 330817077
• Report Number: 1317056-2023-00180
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: CT66LTPD
• Device Lot Number: 5756595
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female