MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SELF-INFLATING RETROGRADE CARDIOPLEGIA CATHETER WITH RETRACTAGUARD TECHNOLOGY; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number RC2014

Device Problem Burst Container or Vessel (1074)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: report of ruptured balloon was confirmed.Balloon was observed to have a rupture with a piece of missing balloon material.Edges of rupture site did not fully match up.All through lumens were found to be patent without any leaks or occlusions.No other visual damage, contamination, or other abnormalities were found.Additional manufacturer narrative: further product assessment is being conducted.When the assessment is complete a supplemental will be submitted.

Event Description

Edwards received information that a retrograde balloon ruptured during an aortic valve procedure.There were issues keeping adequate pressure.The catheter was removed to adjust placement, and when removed, the balloon was burst.A piece of plastic is missing in the patient that was not detected in echo, and is not x-ray detectable.The patient was searched.No patient injury was reported.It was reported that the device was not tested/prepared prior to use.

Manufacturer Narrative

Additional manufacturer narrative: manufacturing records were reviewed and no non- conformities were recorded that would have contributed to this event.No manufacturing deficiency was identified.A definite root cause could not be determined.The complaint trend was reviewed and found to be in control.No further corrective or preventative actions are necessary at this time.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: SELF-INFLATING RETROGRADE CARDIOPLEGIA CATHETER WITH RETRACTAGUARD TECHNOLOGY
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irivne CA 92614
• Manufacturer Contact: trushala nerurkar ; one edwards way; ms lfs33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6542139
• MDR Text Key: 74356854
• Report Number: 3008500478-2017-00033
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

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: 01/05/2020
• Device Model Number: RC2014
• Device Catalogue Number: RC2014
• Device Lot Number: 60710548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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