MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE; 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 02/26/2014

Event Type  Injury  

Event Description

As reported during use of proplege a coronary sinus was perforated.Is it the second event in this hospital with different anesthesiologist.The coronary sinus was engaged in position 2.Insertions attempts were brief.

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 not returned for evaluation.Injuries to the coronary sinus 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
• 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: 3696520
• MDR Text Key: 4261813
• Report Number: 3008500478-2014-00042
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/24/2014
• 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
• Patient Outcome(s): Required Intervention