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

Device Problems Air Leak (1008); Disconnection (1171)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/11/2017

Event Type  malfunction  

Event Description

Patient undergoing repeat left cardiac catheterization for stent occlusion.After the new stent placed, films were taken and cardiologist was ready to post-dilate the stent.Cv technician then noticed that they could not inject contrast, looked at medrad avanta injector and observed black rubber plunger within medrad syringe was off center and/or disconnected.Second cv technician replaced first syringe with new medrad syringe.Injector was connected to tubing during this time, but was not turned on.Patient's arterial pressures were monitored through connection on tubing and no dampening or dissection was noted.While new syringe was being placed, cardiologist directed a 3.5 x 20 balloon across the stent and inflated it to 25 atmospheres.Then, abruptly there was a loud sound followed by a high pitched flow.Air was seen in contrast tubing coming from medrad device.Patient began experiencing st segment changes with decreased blood pressure.Resuscitation efforts were started and were successful.A heart pump was placed for support and patient was transferred to icu.Medrad avanta injector system is no longer in use by this provider.This incident remains under investigation.

• Brand Name: MEDRAD
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6890074
• MDR Text Key: 87205554
• Report Number: 6890074
• 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: Patient
• Type of Report: Initial
• Report Date: 07/17/2017,08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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: 07/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR