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 10/07/2014

Event Type  Injury  

Event Description

Edwards received information that after the use of a proplege, at the end of the case, the coronary sinus was discovered to be perforated, it was unknown when the perforation occurred.The product was in use for 4 hours and was used throughout the case.It was reported that the perforation was repaired by the surgeon.It was reported as being placed fine with the use of fluoroscopy.No fluoroscopy images were available to review.There were no noted anatomical abnormalities.There were no reported complications as a result of the perforation.

Manufacturer Narrative

The device was not returned to edwards for evaluation.Manufacturing records were unable to be reviewed as no lot number was available.Based on the information received we are unable to determine the cause of the coronary sinus perforation, there is no allegation that a product malfunction contributed.Injuries to the coronary sinus are listed as a potential complication in the product ifu.The ifu and training manuals have been reviewed and no inadequacies have been 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.

• 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 parkways; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4232069
• MDR Text Key: 5064710
• Report Number: 3008500478-2014-00132
• 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: Physician
• Type of Report: Initial
• Report Date: 10/08/2014

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?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/06/2014
• 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: 65
• Patient Weight: 70