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

Model Number PR9

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The proplege catheter intermittently delivers retrograde cardioplegia to arrest the heart, which facilitates the ability to visualize and manipulate heart structures.Placement of these catheters into the coronary sinus can be technically challenging and removal of the catheter after initiation of cardiopulmonary bypass may require an interruption of cardioplegia delivery, reliance on antegrade cardioplegia only, or change in operative strategy.There may be cases in which the balloon burst is caused by a needle during the case.In this case, the root cause cannot be determined with the available information.There was no allegation of device malfunction.Per the customer, it was believed that the multiple insertion and removal of the catheter is what caused the rupture.The subject device is not available for evaluation as it was discarded; therefore, the reported event could not be confirmed.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that a pr9 catheter had a balloon rupture during placement.The device was prepped by an anesthesia technician, and no damage or leaks was noted for the catheter and balloon.During the inspection phase, the anesthesiologists completely removed the catheter from the introducer sheath/cordis on three (3) occasions.Once the catheter was properly placed into the coronary sinus, a non-occlusive venogram and then an occlusive venogram was performed.After the occlusive venogram, the balloon was deflated and they noticed blood coming from the lumen into the syringe.The location of the leak is unknown.The leak was only visualized only by floro, waveform, and blood within the syringe (supplied within the pr9 kit).A volume of.8 ml was injected into the balloon.The damaged catheter was replaced with a new catheter and properly inserted and verified with an occlusive venogram prior to the initiation of bypass.Delivery of retrograde cardioplegia was delivered successfully and the case was completed without incident.There was no patient injury.There was no indication from anesthesia that they felt it was a product malfunction.It was assumed that the multiple insertion and removal of the catheter is what caused the rupture.

Manufacturer Narrative

Corrected data: reference (b)(4).

• 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: 10083369
• MDR Text Key: 206535748
• Report Number: 3008500478-2020-00196
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

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 Model Number: PR9
• Device Catalogue Number: PR9
• Device Lot Number: 62917879
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 06/01/2020; 07/23/2020
• Supplement Dates FDA Received: 06/04/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1