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

Model Number 4700

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

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.The subject device was not returned for evaluation.There is insufficient information to conclusively determine the root cause of this event.The root cause of this event remains indeterminable.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.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards received information that glutaraldehyde solution leakage was found from the jar crack prior to use when a distributor representative brought the device to the hospital.There was no patient/user complication reported.

Manufacturer Narrative

The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.

Manufacturer Narrative

H3: evaluation summary: customer report of glutaraldehyde solution leakage was confirmed.The device was received in its original sealed packaging.The jar was observed to have multiple cracks on the bottom of the jar with one crack extended on the side of the jar.At the bottom of the jar four cracks measured 1.96in(a), 0.66in(b), 0.59in(c), 0.35in(d).Crack(a) ran lengthwise on the side of the jar by approximately 4.72in with patch partly extended out.The patch remained inside of 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.The tagalert was blank; water damage was observed on the display.The tagalert start button was pushed and the tagalert remained blank.H10: additional manufacturer narrative: updated sections h3, h6 (device code, type of investigation, investigation findings, investigation conclusions).H11: corrected data: corrected section 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, the root cause of this event cannot be conclusively determined.However, 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.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.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.

• 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: 11283146
• MDR Text Key: 234437674
• Report Number: 2015691-2021-01124
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00690103144178
• UDI-Public: 00690103144178
• Combination Product (y/n): N
• PMA/PMN Number: K082139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1