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

Model Number RC2012

Device Problems Detachment Of Device Component (1104); Decrease in Pressure (1490); Material Perforation (2205); Positioning Problem (3009)

Patient Problems Bacterial Infection (1735); Death (1802); Endocarditis (1834); No Code Available (3191)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned at this time.Therefore, the reported issue cannot be confirmed.Edwards lifesciences will continue to monitor all reported events.If the device or any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards received notification that during use the internal wire of the cardioplegia catheter model rc2012 detached from anchorage and perforated the balloon from the inner lumen.As reported, during first application of the retrograde cardioplegia, the pressure went down, probably due to a displacement of the retrograde catheter; it was difficult to re-position the catheter.During the following applications notable pressure fluctuations occurred.The device was used during the whole procedure, not replaced.The issue was detected when the cannula was removed, after intended utilization.It was stated that it was probably due to a manufacturing issue.Some days after the surgery, the patient died due to subcutaneous bacterial endocarditis (sbe) leading to septis and multi-organ failure (mof).The indication of this surgery was mitral insufficiency, aortic insufficiency and stenosis and sbe.It was done via full sternotomy.No changes in the operative strategy at any time.

Manufacturer Narrative

Evaluation summary: customer complaint of punctured balloon was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the inner wire of the cardioplegia was found dislodged from the cardioplegia and had punctured through the cardioplegia balloon.No other visible damage was observed from returned device.Additional manufacturer narrative: through investigation of this event and evaluation of the subject device, a manufacturing, supplier, design, ifu, and/or labeling defect was not confirmed.The root cause of this event remains indeterminable.

• 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; 1 edwards way; irvine CA 92614
• MDR Report Key: 7351193
• MDR Text Key: 103086629
• Report Number: 3008500478-2018-00062
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Device Lot Number: 60616945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR