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

Model Number MP5100(TW)_

Device Problem Infusion or Flow Problem (2964)

Patient Problem Air Embolism (1697)

Event Date 03/17/2015

Event Type  Injury  

Event Description

It was reported that a patient experienced an air embolism while undergoing a percutaneous coronary intervention.An edwards dpt kit and edwards pressure tubing were connected to a medrad avanta auto injection system that was being used for contrast injection during the procedure.Approximately 3 to 4cc of air was confirmed on the monitor during imaging of the right coronary artery.The patient experienced chest pain and st elevations.Atropine and noradrenaline were given and the symptoms were resolved.There were no further patient complications reported.

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Our lab received one dpt with attached terumo 20ml syringe at the female luer of dp t.The reported issue of air embolism issue was not able to be confirmed during evaluation.However, general evaluation was performed for the returned sample.As received into the laboratory, the connection between the dpt and terumo 20ml syringe appeared tight.No leakage was observed from the unit during leak test.The 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 returned unit during visual examination.There are no indications that this is related to the manufacturing process.No actions 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: 4712174
• MDR Text Key: 5740613
• Report Number: 2015691-2015-00887
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP5100(TW)_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• 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
• Patient Weight: 40