MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA; CANNULA, CATHETER

Model Number OPTI16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Product evaluation was not performed as the device was not returned to edwards.The clinical observation was unable to be confirmed.Manufactured records were unable to be reviewed as the lot number was not provided.Based on the information received, a definitive root cause could not be determined.The ifu provides the following indications: ¿the edwards lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for less than 6 hours.Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.This device is intended for short-term use only (less than 6 hours).To minimize potential vessel damage, a 45 degree insertion angle is recommended.¿ a manufacturing or labeling deficiency was not identified.No further action will be taken at this time.Trends will continue to be monitored through the use of edwards quality systems.

Event Description

Edwards received information that an arterial cannula used for extracorporeal circulation (ecc) and then percutaneous cardiopulmonary support device (pcps) moved from the original implant position and a hematoma was noted at the insertion site.The device had to be removed and a new cannula was inserted into the same site.During this event, the patient required 20 minutes of cardiopulmonary resuscitation (cpr) and there was concerned about possible damage to the brain.Summary of intraoperative events: the patient was taken to surgery urgently for descending aorta replacement surgery due to the rupture of descending aortic aneurysm and cardiac arrest.During the surgery, a perfusion cannula for extracorporeal circulation (ecc) was inserted at the inguinal area and fixed directly to the blood vessel using a tourniquet.When the surgery was ending, the doctor was apprehensive about the cannula not being well secured, but he removed the tourniquet and secured the cannula to the patient's skin.After the surgery, ecc was exchanged to percutaneous cardiopulmonary support device (pcps) because the patient breathing had not improved.At that time, the cannula was not exchanged for another cannula for pcps due to the unstable respiratory status and the cannula for ecc was inserted in the inguinal area.On the second day after the surgery, the patient was able to nod towards the questions, but the lung function was not improved and it was unable to wean off from the pcps.It was observed during tracheal aspiration that the patient slightly moved his leg and the flow of the pcps was lower.A hematoma was then observed at the insertion site of the cannula and it was noted that the position of the cannula had moved.Cpr (cardio pulmonary resuscitation) was performed and the cannula for pcps was removed and a new one was inserted into the same insertion site and pcps was restarted.During this time, it took 20 minutes for the return of spontaneous circulation and the possibly of damage to the brain as a result of these interventions.It was remarked that the patient was swollen and had long distance from the blood vessel to the skin, and the cannula was not well secured, so the doctor was concerned that the blood may leak from the insertion site of the cannula, but did not expect the position of the cannula may move.

• Brand Name: OPTISITE ARTERIAL CANNULA
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5898184
• MDR Text Key: 52831411
• Report Number: 3008500478-2016-00029
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• PMA/PMN Number: K073559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: OPTI16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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 Outcome(s): Other; Required Intervention