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

Model Number 4700J

Device Problem Packaging Problem (3007)

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

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Edwards received information that glutaraldehyde solution leaked out from a 4700 pericardial patch jar before use.The leakage was found while it was stored in a hospital incubator.No information was provided by the hospital on how the product was stored in the incubator or whether it had been bumped anywhere since it was delivered to the hospital.

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.

Manufacturer Narrative

H3: evaluation summary: customer report of glutaraldehyde solution leakage was confirmed.As received, shelf box was soaked with patch jar still sealed within its shrink wrapping.The patch jar had one crack (a), approximately 2.10 inch long, on the bottom of the jar that extended on the side of the jar by 0.40 inch.The patch remained inside the jar with approximately 60% glutaraldehyde solution left inside.As received, tag alert displayed 'ok'.H10: additional manufacturer narrative: updated sections d9, h3, h6 (type of investigation) the reported event was confirmed through preliminary evaluation of the product.The reported event is pending final evaluation analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

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, damage to the package/product was 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.Since the device was delivered to the hospital in late august 2021 and the date of the event is (b)(6) 2021, it is likely the event occurred while in the care of the customer.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12918951
• MDR Text Key: 283236513
• Report Number: 2015691-2021-06629
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4700J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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