MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH

Model Number 4700

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.The device evaluation is anticipated, but has not yet begun.A supplemental report will be submitted once the evaluation is completed.

Event Description

Edwards received information that the packaging of the pericardial patch was wet before use.The wetness appeared to be from liquid from the jar.The jar was not opened and the patch was not used.There was no harm or complications to the patient.

Manufacturer Narrative

Evaluation summary the shipment was returned to edwards for analysis.As received, the shelf box, tagalert, and product related paperwork were received wet with glutaraldehyde solution.The tagalert displayed "ok." the shrink wrap on the jar remained intact.The patch remained inside the jar, however there was no glutaraldehyde solution left in the jar.The bottom of the jar had four cracks, and the side of the jar had 2 cracks.The cracks measured approximately 10mm-40mm.Evaluation summary the customer report of wet product was confirmed; however, the root cause for the cracks remain unknown.The patch did not interact with a patient nor contributed to an adverse event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: PERICARDIAL PATCH
• 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: trushala nerurkar ; one edwards way; m/s lfs-33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6175612
• MDR Text Key: 62848703
• Report Number: 2015691-2016-03713
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K833763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2018
• Device Model Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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