MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H9656518002171
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Sudden Cardiac Death (2510)
Date of Event	01/28/2016
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1317056-2016-00024
• Device Sequence Number: 2433249
• Product Code: OEZ
• UDI-Device Identifier: H9656518002171
• UDI-Public: H9656518002171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 05/31/2018
• Device Catalogue Number: H9656518002171
• Device Lot Number: 4924376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2016
• Supplement Date Received by Manufacturer: 01/30/2016
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 06/30/2017
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male