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

Model Number 4700

Device Problems Delivered as Unsterile Product (1421); Structural Problem (2506)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.Based on the information received the cause of the event cannot be determined.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards received information that the lid of the patch jar was placed askew and not fully closed when a medical engineer attempted to open it in the non-sterile field at operating room before use.There was no liquid leakage observed.The patch was not used.

Manufacturer Narrative

Not fully closed" was confirmed.As received, the patch jar was in opened shelf box packaging with broken shrink wrapping on the patch jar lid.The patch jar was not fully screwed on the jar threading.No leakage or other damages were observed from the patch jar.Patch was inside patch jar full of solution and no visible inconsistencies were observed.Photo provided was consistent with lab findings.Additional manufacturer narrative: updated sections.

Manufacturer Narrative

An engineering evaluation was performed.Edwards received information that the lid of the patch jar was placed askew and not fully closed when a medical engineer attempted to open the shrink wrap over the lid in the non-sterile field at operating room before use.There was no liquid leakage observed.The patch was not used.The device was returned for evaluation.A photo that the medical engineer took was provided.See attachments.Per product evaluation, ¿customer report that "lid of the patch jar was placed askew and not fully closed" was confirmed.As received, the patch jar was in opened shelf box packaging with broken shrink wrapping on the patch jar lid.The patch jar was not fully screwed on the jar threading.No leakage or other damages were observed from the patch jar.Patch was inside patch jar full of solution and no visible inconsistencies were observed.Photo provided was consistent with lab findings.¿ the dhr review was performed and no related nonconformances were found.In addition, there are no findings from product evaluation to confirm an edwards manufacturing defect.Since there was no leakage observed, this suggest that the jar was properly sealed, even while in transit.It¿s possible that this issue occurred when the customer attempted to open the jar with the shrink seal still intact, causing the lid to be ¿askew¿, however, the definitive root cause could not be conclusively determined.An edwards manufacturing defect is not confirmed since a lid ¿placed askew¿ would not have passed manufacturing inspections.No further corrective actions are required.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, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9234959
• MDR Text Key: 188718416
• Report Number: 2015691-2019-03937
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K082139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1