MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE CORONARY SINUS CATHETER; 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 11/17/2014

Event Type  Injury  

Event Description

Edwards received information that a coronary sinus injury occurred during the use of a proplege coronary sinus catheter.

Manufacturer Narrative

The device was not retained by the hospital for evaluation.At this time, there is no allegation of product malfunction but only an adverse event associated with the use of an edwards device.Injuries to the coronary sinus are listed as a potential complication in the product ifu.The ifu further notes: warning: if resistance is met, stop and re-evaluate proplege device position.The proplege device should not be advanced if resistance is felt, as doing, so would cause the proplege device to bend or buckle.Aggressive advancement in an attempt to engage the ostium may result in perforation or other injury.Warning: aggressive advancement of the guidewire in an attempt to engage the ostium may result in perforation or other injury.No device malfunction is indicated in the report and the events reported are included in the labeling.No actions are needed at this time this type of event is a known potential complication and/or adverse event, is included in the labeling/training materials, and in the information we provide to help avoid the issue.All labeling and training appropriately address the risk.Manufacturing records could not be reviewed as a lot number is unknown.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: PROPLEGE CORONARY SINUS CATHETER
• 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: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4361903
• MDR Text Key: 20062996
• Report Number: 3008500478-2014-00152
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2014

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?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: No
• 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