MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC PERFUSION CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZC21A

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.A definitive root cause can not be determined at this time.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a pin hole was found on the cannula during use.Reportedly, air inclusion was observed during de-airing before use.The air was removed and the heart-lung machine was started.However, blood spurt from the cannula body right after the heart-lung machine was started and a pin hole was found from where the blood was leaked.It was suspected that the air inclusion was also occurred from the pin hole, but the pin hole was not noticed at that time.The cannula was exchanged immediately and the operation was completed without problem.Treatments such as blood infusion was not necessary, and there were no patient complications reported.

Manufacturer Narrative

Device was returned and evaluated.Report of cannula leakage was confirmed.As received, cannula body was found punctured approximately 10 cm proximal from cannula tip resulting in cannula leakage.No other visual damage, contamination, or other abnormality was found on the returned device.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.However, it is possible that handling of the device during the procedure may have contributed to the damage.Visual inspections are in place to identify this issue prior to distribution of the product.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: EZ GLIDE AORTIC PERFUSION CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6494200
• MDR Text Key: 72882199
• Report Number: 3008500478-2017-00022
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: 11/01/2019
• Device Model Number: EZC21A
• Device Lot Number: 60615552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• 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