MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AORTIC PERFUSION CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number ARS020CS

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

Patient Problem Injury (2348)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded by hospital staff.Manufacturing records were unable to be reviewed as no lot number was provided.Based on the information received, a manufacturing related issue was not identified.A definitive root cause could not be determined; however, operational context most likely contributed to this event.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

Edwards was notified that a patient sustain an aortic injury.An edwards cannula was pushed into the aortotomy site too far and the incision site was repaired.The patient was stable following the case.

• Brand Name: AORTIC PERFUSION CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: trushala nerurkar ; 1 edwards way; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6167894
• MDR Text Key: 62184715
• Report Number: 3008500478-2016-00040
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2016

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: ARS020CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/12/2016
• 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