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

Model Number EZC24A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.A definitive root cause cannot be determined at this time.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems, and if appropriate investigation will be performed.

Event Description

Edwards received information that the subject device was found to have a hole in the package.

Manufacturer Narrative

Device evaluation: the product was returned for evaluation.Customer complaint of "hole in the package" was confirmed.As received, the sealed sterile barrier pouch packaging was observed to have a cut in the pouch.No other visual damage, contamination, or other abnormalities were found.Additional manufacturer narrative: manufacturing records were reviewed and no non- conformities were recorded that would have contributed to this event.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.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; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; ms mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6616434
• MDR Text Key: 76832584
• Report Number: 3008500478-2017-00036
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: EZC24A
• Device Catalogue Number: EZC24A
• Device Lot Number: 60504498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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