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

Model Number 4700

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

Additional 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.A manufacturing related issue was not identified.A definitive root cause could not be determined at this time.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received information that particulates were found on outer surface of the plug when the customer opened the package before use.The device was not used and replaced to a new one.

Manufacturer Narrative

H3: device evaluation: customer report of "particulates on the outer surface of the plug" was confirmed.As received, shelf box tamper resistant seal was broken and patch jar was not sealed within its shrink wrapping.Brown residue was visible inside jar lid threads, jar lid, and on the surface of patch jar plug.No leakages or other contamination were observed from the patch jar, jar lid, jar lid thread, jar thread, and shelf box packaging.The use by date was 2023-09-26.Patch was inside patch jar with solution level approximately filled to the top of jar thread and no visible inconsistencies were observed.Tagalert was returned with device.Tag alert displayed "ok".Photos attached was consistent with lab findings.H10: additional manufacturer narrative: updated sections d10, h3, and h6.

Manufacturer Narrative

Although chemistry could not conclusively confirm the identity of the brown material, it visually resembles dried glutaraldehyde.The current manufacturing process is conducive to glut expulsion from the 12oz jar, leading to glut getting on the operator¿s/inspector¿s gloves and transferred to the jar/plug/lid.The operators place the plug loosely on the jar, then completely fill to eliminate air bubbles, which can expel excess glut from the jar.It is difficult to visibly identify any residual glut on the jar/plug/lid during use; however, it can become visible later after it dries.This event is not considered to be a manufacturing defect.Operator awareness communication has been performed.There is no risk to the patient since the brown material is most likely dried glut.Per the instructions for use (ifu), "the pericardial patch is packaged sterile in a plastic container with a rubber stopper and a screw-cap closure and seal.Before opening, the container should be carefully examined for evidence of damage (e.G., a cracked container or lid), leakage, and broken or missing seals.As long as the container and its seals remain intact, the tissue will remain sterile." additionally, "pericardial patches from containers found to be damaged, leaking, without adequate glutaraldehyde, or missing intact seals must not be used for human implantation.".

Manufacturer Narrative

H10: additional manufacturer narrative: ir spectrum of the brown residue on outer plug showed similar absorption characteristics when comparing to calcium phosphate like material.

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: 10159354
• MDR Text Key: 195933074
• Report Number: 2015691-2020-12183
• 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,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1