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

Catalog Number	H965910313031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HIGH PRESSURE CONTRAST INJECTION LINE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7011256
• Report Number: 1317056-2017-00094
• Device Sequence Number: 18957118
• Product Code: DQO
• UDI-Device Identifier: H965910313031
• UDI-Public: H965910313031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K822100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965910313031
• Device Lot Number: 5058013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention