MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

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

Patient Problem Perforation (2001)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing records were unable to be reviewed due to no lot number being provided by the customer.The device was not returned for evaluation because it was discarded by the hospital.Right ventricular perforations are identified as a potential complication in the instructions for use (ifu).The ifu and training manuals were reviewed, and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.If new information is received, a supplemental report will be filed.

Event Description

Edwards received information that one (1) hour into the use of a peripheral retrograde cardioplegia device a perforation of the right ventricle occurred.The procedure was a robotic mvr with maze that was converted to a full sternotomy to repair the perforation.The patient, a (b)(6) female, was reported to be stable.The surgeon was an intermediately experienced, but low volume user of the device.Tee and fluoroscopy were used for device placement; images were not available for review.Per report, the device was used per the instructions for use.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• 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; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; m/s mle 8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5287675
• MDR Text Key: 33228097
• Report Number: 3008500478-2015-00074
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120780
• 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: 11/16/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: PR9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/10/2015
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 64