MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / NAVILYST MEDICAL; HIGH PRESSURE CONTRAST INJECTION LINE

Catalog Number H965910313031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/12/2017

Event Type  Injury  

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 (b)(6) 2017 angiodynamics complaint report was reviewed for the contrast injection lines product family and the failure mode "air bubbles." no adverse trend was indicated.Without receiving product for evaluation, the root cause of the reported event is unable to be determined.A possible root cause may be that the end user did not adequately secure connections between the cil and the device to which they were connecting, and that the connections were not "finger tightened" prior to use as it is stated in the directions for use (dfu) provided with the contrast injection line.The dfu contains the following statements, "all connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards." (b)(4).

Event Description

Angiodynamics was made aware of the event regarding a contrast injection line via voluntary user medwatch # mw5072632: "patient was having cardiac angiogram, all tubing and medrad injection was primed and backprimed.Contrast was injected and patient started to lose blood pressure and heart rate and then coded.The patient was taken to icu.On review of the cath films the next morning it was determined that the patient had an air embolism.The tubing that had been used during the procedure had been discarded and the team was not able to inspect for damage or if connections were sealed after contrast had been injected through the tubing.The injector was removed from service and checked out and found to be working properly.".

• Brand Name: ANGIODYNAMICS / NAVILYST MEDICAL
• Type of Device: HIGH PRESSURE CONTRAST INJECTION LINE
• 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: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 7011256
• MDR Text Key: 91411882
• Report Number: 1317056-2017-00094
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H965910313031
• UDI-Public: H965910313031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2017

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
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965910313031
• Device Lot Number: 5058013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• 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): Required Intervention