MAUDE Adverse Event Report: NAVILYST MEDICAL, INC., AN ANGIODYNAMICS COMPANY NAMIC STANDARD PERIPHERAL VASCULAR ANGIOGRAPHIC KIT; OXYGENATOR, CARDIOPULMONARY BYPASS

Lot Number 60041082

Device Problem Break (1069)

Patient Problems Air Embolism (1697); Bradycardia (1751); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pallor (2468)

Event Date 05/07/2015

Event Type  No Answer Provided  

Event Description

A patient was in the catheterization lab for a heart catheterization.An air embolism occurred.Probable cause: defective manifold system (namic kit, lot # 60041082, item sequestured).Patient conditions: heart rate bradycardia to 43, blood pressure (bp) 91/61, chest pain, pale.The patient was treated with atropine, neosynephrine, epinephrine, and aspirating air from the right coronary artery (rca).The patient was stable at end of the procedure.

• Brand Name: NAMIC STANDARD PERIPHERAL VASCULAR ANGIOGRAPHIC KIT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): NAVILYST MEDICAL, INC., AN ANGIODYNAMICS COMPANY; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 4934791
• MDR Text Key: 6437105
• Report Number: 4934791
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Lot Number: 60041082
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2015
• Patient Sequence Number: 1
• Patient Age: 69 YR