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

Model Number PR9

Device Problem Human-Device Interface Problem (2949)

Patient Problem Cardiac Perforation (2513)

Event Date 02/19/2014

Event Type  Injury  

Event Description

It was reported by the sales rep that there was a cardiac perforation during the use of the proplege coronary sinus catheter, pr9.Surgeon needed to repair, no further information stated.

Manufacturer Narrative

The device was discarded by the hospital and unavailable for evaluation.There was no allegation of a product malfunction in this event only a cardiac injury during the placement of the proplege device.The instructions for use give guidance around device placement as: ¿once the proplege device can be seen in the right atrium, advance gently while applying counter clockwise torque to align the curve of the device with the intra-atrial septum to place the proplege device tip at the ostium of the coronary sinus.In the training materials there is specific guidance to imaging in regards to navigating the anatomy.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.¿ in the reported complaint there is no indication the physician did not do as instructed by the ifu and training manuals.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.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.At this time, there will be no corrective or preventative actions due to this event.

• Brand Name: 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 ; 8015655100
• MDR Report Key: 3682320
• MDR Text Key: 4240425
• Report Number: 3008500478-2014-00034
• 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
• Report Date: 02/19/2014

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?: No
• Distributor Facility Aware Date: 02/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2014
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/17/2014
• 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): Other