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 Sinus Perforation (2277)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

Perforation of the coronary sinus is a serious, well characterized complication of retrograde cardioplegia.Its causes are well known but sometimes difficult to predict.Management of this complication is well described in the literature.Edwards has reviewed many of these reports and has found that the root cause is typically related to a combination of vessel size/fragility and placement issues of the catheter.No manufacturing non-conformance have been associated with the historical events which have been reported.Operational context most likely contributed to this event.There was no allegation of product malfunction.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Injuries to the coronary sinus are listed as a potential complication in the product ifu.The 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 received information that a patient sustain a coronary sinus perforation during the use of a retrograde catheter.The injury occurred during placement.The surgical team performed a non-occlusive venogram and noticed dye outside of the coronary sinus at which time the surgical team stopped and alerted the surgeon.There were no difficulties with placement.On the first venogram, it was noticed that the catheter was placed shallow and was therefore advanced to achieve proper positioning.The anesthesiologist was using trans-esophageal echo and fluoroscopy for placement.A guidewire was not needed and therefore not used.The patient did not appear to have any abnormal anatomy or friable tissue and there were no technical challenges with placement at any time.There was no bending or bowing of the catheter seen on echo or fluoro.The catheter was placed between 34-35 cm.There was no manipulation of the heart after placement as the perforation occurred prior to the start of the surgery.The surgery converted from a minimally invasive procedure to an open sternotomy and the coronary sinus was able to be repaired by the surgeon.The customer is not alleging that the catheter caused the issue.The patient did fine.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• 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: 6391350
• MDR Text Key: 69483801
• Report Number: 3008500478-2017-00013
• 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: 02/14/2017

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: 02/14/2017
• Initial Date FDA Received: 03/09/2017
• 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