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

Model Number PR9

Device Problem Entrapment of Device (1212)

Patient Problem Cardiac Perforation (2513)

Event Date 03/03/2014

Event Type  Injury  

Event Description

It was reported by the sales rep that during the case a right ventricle perforation occurred during the placement of a proplege coronary sinus catheter, pr9 for a planned rat mini avr.There were two anesthesiologists involved in attempting the placement prior to an emergency sternotomy intervention to repair the perforation in the right ventricle by the surgeon.The repair was completed and followed by an open avr.During the attempted placement of the pr9, there was nothing of significant note visually from echo, fluoro, or pressure tracings to warn of right ventricular disruption.At one point during the attempt, there was a notable drop in the patient's blood pressure following which levafed was given and normal blood pressure was reestablished.After about 20 minutes of trying to engage the coronary sinus by the first anesthesiologist, the second anesthesiologist took over and following approximately 2 balloon inflations to test for ventricularization and one venogram another significant blood pressure drop was noted.At this point the surgeon was paged stat and a sternotomy was performed to repair the hole in the right ventricle.It should be noted at one point the sales rep had observed the coronary sinus pressure line had become coiled around the body of the catheter/device.The sales rep alerted the perfusionist and he stopped and untangled the catheter and proceeded attempting placement without success.

Manufacturer Narrative

Device to be evaluated upon return to manufacturer.

Manufacturer Narrative

Evaluation: during visual inspection of the returned device there were no issues found with the catheter shaft and there were no defects found with the tip of the device.The device was evaluated and there was no defect noted on the returned device.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 and 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 8402 0
• 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: 3705819
• MDR Text Key: 4265929
• Report Number: 3008500478-2014-00045
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: PR9
• Device Lot Number: 59654235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/03/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2014
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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