MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).Vascular perforations may occur with the use of several of our devices.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.In this case, it was reported that there was bleeding from the coronary sinus (cs) after use of the device.The root cause cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have contributed to the event.Attempts has been made to request for product return.The subject device is not available to be returned for evaluation.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards received notification that bleeding from the coronary sinus occurred soon after the use of the pr9 device for plegia in an rat aortic valve replacement procedure.The procedure was later converted to thoracotomy.As reported, during use of the device, the surgeon experienced some difficulties in viewing the position of the pr9.Pressures and plegia were checked and all went well.The procedure went in the best way, but upon removing the cpb, they noticed bleeding from the coronary sinus, thus, converted to thoracotomy and the surgeon closed the small hole with dots and pledgets.The patient left the operating room and everything went well.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8798538
• MDR Text Key: 151308082
• Report Number: 3008500478-2019-00153
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2019
• Device Model Number: PR9
• Device Catalogue Number: PR9
• Device Lot Number: 61913045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/28/2019; 07/23/2020
• Supplement Dates FDA Received: 08/29/2019; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1