MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE CORONARY SINUS CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Perforation (2513)

Event Date 04/09/2014

Event Type  Injury  

Event Description

It was reported that the pr9, proplege coronary sinus catheter was successfully placed using tee and fluoro in patient for avr without event.Upon opening sternum, surgeon noticed blood in pericardium.Could never definitively determine source of bleeding, although it did stop.Surgeon, anesthesiologist suspected possible cs or rv puncture but could never be determined.Dye "stain" was not observed during placement of pr9 during non-occlusive and occlusive venograms.Avr performed successfully.No other patient events reported.

Manufacturer Narrative

Device evaluation is anticipated upon product return from the customer.

Manufacturer Narrative

Correction: this 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.The device was discarded at the hospital.The event was presented by the edwards sales representative and the device was not returned for evaluation.Cardiac injuries is 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: continuously monitor the pressure at the tip of the catheter.A pressure change that indicates the catheter has entered the right ventricle should be noted.Do not advance the catheter further if the tip is in the right ventricle as perforation or other injury can occur.Warning: aggressive advancement of the guidewire in an attempt to engage the ostium may result in perforation or other injury.No device malfunction is indicted in the report and the events reported are included in the labeling.No actions are needed at this time.For complaints/reports of injury without a product problem, this type of event is a known potential complication 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 were reviewed and there were no related nonconformances.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: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3753818
• MDR Text Key: 4466924
• Report Number: 3008500478-2014-00055
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

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 Expiration Date: 11/01/2014
• Device Model Number: PR9
• Device Lot Number: 59683527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2014
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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