MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number 4700

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that, upon receipt, two (2) 4700 bovine pericardial patches were found to be leaking within the shipping box.There was no physical damage to the shipping box but the shelf boxes were found to be wet and discolored.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, d9, g3, g6, h2, h3, h6 h3: evaluation summary: customer report of solution leakage and damaged shelf box were confirmed.The device was received in its original packaging; patch jar was still sealed within its shrink wrapping.The jar was observed to have multiple cracks on the bottom of the jar with two cracks extended on the side of the jar.At the bottom of the jar five cracks measured 32mm, 24mm, 12mm, 23mm, 17mm.The fourth crack ran lengthwise on the side of the jar by approximately 58mm and the 6th crack at 20mm.The patch remained inside of the jar.There were no glutaraldehyde solution in the jar.Yellow stains were apparent at multiple locations on the shelf box.The patch had a few creases and was dehydrated.Tagalert was not returned.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 is no allegation of a device malfunction and there is no device failure, an engineering evaluation is not required.

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14231512
• MDR Text Key: 290797546
• Report Number: 2015691-2022-05444
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Device Lot Number: 64130017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• Patient Sequence Number: 1