MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number CVDPT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Air Embolism (1697)

Event Date 07/02/2015

Event Type  Injury  

Event Description

It was reported that a small amount of air inclusion was noted in the left coronary artery during coronary angiography.An edwards dpt kit was connected to the medrad avanta injection system during the procedure.When the customer injected the contrast for the first imaging, a small amount of air was confirmed in the left coronary artery.St elevation was noted on the monitor, but there was no change in patient's condition, therefore the procedure was completed without incident.There were no patient injuries reported.

Manufacturer Narrative

Supplemental will be submitted upon product evaluation.

Manufacturer Narrative

Received one dpt without any attached components.General evaluation was performed for the returned sample.No leakage was observed from the dpt during leak test.Dpt zeroed and sensed pressure accurately on the pressure monitor.Electrical testing showed that dpt electronic components were intact because both input impedance and output impedance were within specifications.The zero-offset also met specifications.No visible damage/defect was found from the dtp during visual examination.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No further action will be taken at this time.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4960305
• MDR Text Key: 6252992
• Report Number: 2015691-2015-01924
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CVDPT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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