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

Model Number PR9

Device Problem Human-Device Interface Problem (2949)

Patient Problem Hematoma (1884)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It was reported that during the used of a proplege coronary sinus catheter, pr9 "first injection of contrast to verify placement depth in cs, it was noted that the device was too far in, could not see the posterior branch filling, so the device was pulled back 2mm.Upon contrast injection to check placement there was a huge filling around the cs that was not going away.It was decided to do a sternotomy to examine the cs for injury.No perforation, small branch disruption causing a hematoma in the fatty tissue surrounding the cs.No intervention needed.".

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.The device was discarded at the hospital.The event was presented by the edwards sales representative and the device was not returned for evaluation.Injuries to the coronary sinus and vasculature 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: guidewire should only be used with fluoroscopy to avoid coronary sinus 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 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, it¿s important to show that the 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 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: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3835678
• MDR Text Key: 4501991
• Report Number: 3008500478-2014-00072
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2014

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: 07/01/2014
• Device Model Number: PR9
• Device Lot Number: 59683519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report Sent to FDA: 05/06/2014
• Distributor Facility Aware Date: 05/06/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2014
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2014
• 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): Other
• Patient Age: 51 YR