MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H9656518002171

Device Problem Insufficient Information (3190)

Patient Problems Air Embolism (1697); Sudden Cardiac Death (2510)

Event Date 01/28/2016

Event Type  Death  

Manufacturer Narrative

Angiodynamics has requested that the hospital provide the used samples and results of the 3rd.Party investigation.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).The initial mdr for this complaint record was originally submitted on 01/30/2016 via usps.Due to e-submitting requirements, it was not accepted.Per request, this initial mdr report is being submitted via the esubmitter program.The original mdr has been attached for reference.

Event Description

As reported, air was injected into the patient during a cardiac angiogram procedure utilizing an angiodynamics convenience kit.Manifold was prepared in usual fashion, connections checked and all were secure.Contrast was primed.After tig catheter insertion was connected by md both catheter and manifold flushed.Two pictures were taken and on the third picture it was noted that there was air emboli in the circumflex.Patient decompensated, coded and died after prolonged resuscitation.The used components have been provided to a 3rd party hired by the hospital to investigate the root cause of the event.

• Brand Name: ANGIODYNAMICS
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny 12801, ny ; 7424488
• MDR Report Key: 6680293
• MDR Text Key: 197814091
• Report Number: 1317056-2016-00024
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: H9656518002171
• UDI-Public: H9656518002171
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: H9656518002171
• Device Lot Number: 4924376
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2015
• 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): Death
• Patient Sex: Male