MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD AVANTA; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Lot Number 173303

Device Problem Air Leak (1008)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 01/18/2018

Event Type  malfunction  

Event Description

After diagnostic angiography the circ graft was stented.After stenting they used it and it was then noticed under fluoro that there was an air bubble in the artery.They then went in with a pronto to suck out the air.Visually, dr did not see any more air.Then patient then went into vf arrest and was shocked once.Pt was transferred to the icu and recovered just fine.Doctor on case said it was the tubing.

• Brand Name: MEDRAD AVANTA
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7291914
• MDR Text Key: 100799555
• Report Number: 7291914
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/19/2019
• Device Lot Number: 173303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; YES... EXCHANGED SEVERAL WIRES AND BALLOONS THROUGH
• Patient Age: 78 YR