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

Catalog Number	H749910516021
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
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 june 2019 complaint report was reviewed for the contrast injection line product family for the failure mode "device air bubbles." no adverse trend was indicated.The reported complaint description cannot be confirmed, nor can a root cause be established, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The directions for use packaged with the contrast injection line contains the following warnings: " ensure that you are making secure connections when using this device to prevent the introduction of air into the system that could result in embolism and in rare instances of death.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.Examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism and in rare instances death." ((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), end user hospital was utilizing a 60" flexcil contrast injection line (with f-m) fittings along with an edward's extension tube which was connected to a namic stopcock."as preparation, the first air inside injector was removed and the tubing connections were securely tightened.Prior procedure, contrast media was flashed into a 10ml syringe of the operator side.Then angiography procedure began by an injector (5ml injected, 2ml/sec).Immediately air was observed in the catheter on the image.Therefore, the operator stopped injecting the contrast media immediately and stopped the angiography procedure." no patient injury or complications were reported.The used devices were discarded at the hospital.

• Brand Name: ANGIODYNAMICS / FLEXCIL
• Common Device Name: HIGH PRESSURE CONTRAST INJECTION LINE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8875673
• Report Number: 1317056-2019-00106
• Device Sequence Number: 19430765
• Product Code: DQO
• UDI-Device Identifier: H749910516021
• UDI-Public: H749910516021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: H749910516021
• Device Lot Number: 5393815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/08/2019
• 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: Other