MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / NAVILYST MEDICAL; CONVENIENCE KIT

Catalog Number H965652100911

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Angiodynamics has reached out to the end user hospital to obtain additional information regarding the event/problem and device samples, if available.Upon receipt of additional information and subsequent completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

Issue reported on user medwatch # (b)(4).End user hospital received procedure packs from cardinal health containing a convenience kit from navilyst medical/angiodynamics.The hospital is indicating that the one-way valves on the waste port of the manifold may allow air to be introduced into the manifold ("which is supposed to be an airless system").Additionally, it was stated that, "the syringes that come in the pack are not able to be refilled quickly enough without introducing air into the system." no samples have been returned.No patient complications or injury were reported.

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The march 2018 angiodynamics complaint report was reviewed for the closed system product family and the failure mode "device - air bubbles." this does not constitute an adverse trend.In addition, this is the only reported complaint for this air bubble failure mode for the closed system product family in the past 15 months.Multiple attempts were made by angiodynamics to obtain information to determine if the valve could be a contributing factor in the "air bubbles".The end user stated that although the air was noted to be present during the setup, it never was injected into a patient.They stated that the manifold handle was turned "off" to the in-line check valve/waste bag when the fluids were being aspirated into the manifold.According to the description this is when the air bubbles were observed.With the manifold handle turned "off" the in-line check valve could not affect any fluid flow and allow air bubbles to enter the lumen.The information from the end user hospital does not make sense.No product was available for investigation, therefore the connections within the system and the individual components could not be functionally verified.The setup described by the user could not be used to replicate the reported device malfunction.Based on the description given the valve was functioning as intended.The end user hospital stated that they were able to inject into the waste bag without resistance.The root cause for the air bubble issue is not likely due to the manufacturing of the in-line check valve in the waste bag line as reported.Clinically, there could be many different things that could contribute to air bubbles when priming the lines for setup.For instance, they are not using a pressurized saline bag for fluids, using non- large bore tubing per the end user, the viscosity of the contrast, even potentially the rate at which the operator is pulling the fluids back to fill the syringe.The end user hospital has requested a change to their convenience kit to replace the waste bag with the in-line one-way check valve with a waste bag that does not contain an in-line check valve.This change has been implemented.((b)(4)).

• Brand Name: ANGIODYNAMICS / NAVILYST MEDICAL
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7372919
• MDR Text Key: 103544633
• Report Number: 1317056-2018-00032
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: H965652100911
• Device Lot Number: 5262713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1