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

Model Number PR9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Edwards received information that a coronary sinus injury occurred during placement of a proplege catheter.The patient also sustained right ventricular hematoma and pulmonary artery hematoma due to the placement of the proplege catheter.The anesthesiologist used both fluoro and tee imaging to insert the catheter into the patient with multiple non-occlusion venograms to access coronary anatomy.No guidewire was utilized for coronary sinus advancement.It was noticed on fluoro that there was an acute angle bend at about 10 cm from the tip.No ventricularization wave form was observed, but high pressure readings were noted.The anesthesiologist was not able to flush the catheter while it was in the patient; however, prior to placement the catheter functioned normally.No balloon inflation was performed.It was reported the patient did not require intervention to treat the coronary sinus injury because the injury appeared small in caliber.No further adverse events were reported and the patient was reported to be stable.

Manufacturer Narrative

Device not returned.Based on the information received, edwards is unable to determine the cause of the coronary sinus perforation.Injuries to the coronary sinus are listed as a potential complication in the product instructions for use (ifu), which have been reviewed and found to be adequate.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.

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation.The reported ¿acute angle bend¿ was confirmed.Visual inspection, functional testing and dimensional measurements were performed on the returned device condition as received.A kink was identified at 85 mm from the tip of the device.No other signs of damage were observed.The outer diameter of the shaft was measured and found to be within the acceptable range per the design requirement.The device lumens were successfully flushed; however, resistance was noted when the shaft was bent at the location of the kink.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Based on the information received, the most probable root cause was operational context.The patient¿s small in caliber and possibly shorter than normal coronary sinus likely also contributed to unsuccessful placement of this device.Neither a product deficiency nor a manufacturing defect was identified.The instructions for use (ifu) and training manuals were reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The high pressures observed could have been indications of the malpositioned location of the device during placement.In addition to insertion instruction, the ifu states, ¿warnings and precautions: once placed in the body, the proplege device should be manipulated only while being observed using fluoroscopy and/or transesophageal echocardiography (tee) and while monitoring pressure at the proplege device tip.¿ ¿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.¿ and ¿once placed in the body, the proplege device should be manipulated only while being observed using fluoroscopy and/or transesophageal echocardiography (tee) and while monitoring pressure at the proplege device tip.¿ perforation of the coronary sinus is a serious, well characterized complication of retrograde cardioplegia.Its causes are well known but sometimes difficult to predict.Management of this complication is well described in the literature.Edwards has reviewed many of these reports and has found that the root cause is typically related to a combination of vessel size/fragility and placement issues of the catheter.No manufacturing non-conformance has been associated with the historical events which have been reported.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• 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 ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4331067
• MDR Text Key: 20291627
• Report Number: 3008500478-2014-00149
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

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 Expiration Date: 06/01/2015
• Device Model Number: PR9
• Device Lot Number: 59847021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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
• Patient Age: 65 YR
• Patient Weight: 98