MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH; PATCH, PERICARDIAL

Model Number 4700

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that glutaraldehyde got leaking out from a crack in the patch jar before use.The jar was stored in the refrigerator and the leakage was observed from the box.When the box was opened, solution leakage from the crack in the jar was found.The patch was not used and there was no injuries to the patient and health care provider.

Manufacturer Narrative

H10.Additional manufacturer narrative: any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, it was reported that the box was opened and the cracked jar was found to be leaking fluid.The device was returned for evaluation and the customer report of glutaraldehyde solution leakage and cracked jar was confirmed.As received, shelf box and paperwork were completely soaked.Patch jar was still sealed within its shrink wrapping when received.As received, the patch jar had multiple cracks on the bottom of the jar with one crack extended on the side of the jar.Measurements were taken of each crack: crack a was approximately 7.50" long; crack b was approximately 0.40" long; crack c was approximately 0.70" long; crack d was approximately 0.55" long.Crack a extended along the side of the jar with patch partly extended out.The patch remained inside the jar with a small amount of glutaraldehyde solution left inside.The patch had a few creases, which was likely due to the patch being folded in the jar and not being fully submerged in solution.Damage to the package/product is most likely the result of mechanical damage incurred while in the care of the customer or in transit from the courier, and not an indication of a device malfunction.There as no allegation of a device malfunction and there is no device failure.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: PATCH, PERICARDIAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9521772
• MDR Text Key: 188699845
• Report Number: 2015691-2019-04932
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K833763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Device Lot Number: R-19G4194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1