MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR V-PATCH; MESH, SURGICAL, POLYMERIC

Model Number 31200

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Hospital reported coating started flaking off with minimal manipulation.Mesh had to be removed and a new mesh was placed.

Event Description

N/a.

Manufacturer Narrative

The mesh was returned and evaluated to determine why the omega 3 fatty acid (o3fa) coating was flaking off the mesh.Upon receipt the v-patch mesh was removed from the packaging and inspected.The mesh showed that the o3fa coating was flaking in a few spots around the circumference of the mesh.It is clear that the mesh had come in contact with the patient as there was noticeable blood on the returned mesh.There were also multiple sutures still within the mesh.There was a spot also that appears to have been cut with a scalpel or scissor.In an attempt to have more coating flake off the mesh was rolled onto itself distressing the mesh more than it would under normal circumstances.The result was that the coating stayed intact.The remaining coating did not flake off.A review of all lot history records for the c-qur v-patch 31200 small 1.7x1.7 (4.3cm) was conducted.All in-process specifications and release criteria were met.No deviations or non-conformances were reported in any of the manufacturing and sterilization processes.All acceptance criteria were met.The instructions for use (ifu) states to inspect the mesh product for any noticeable damage to the knit construction of the mesh.Do not use a c-qur v-patch mesh that has any noticeable damage or disruption to the knit construction of the mesh as this may lead to device failure.Summary/conclusion - based on the results of the investigation the root cause of the omega 3 fatty acid (o3fa) coating flaking off during handling could not be determined.Prior to being shipped from the manufacturing site the c-qur v-patch mesh met all product requirements.

• Brand Name: C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8819953
• MDR Text Key: 152207494
• Report Number: 3011175548-2019-00797
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312003
• UDI-Public: 00650862312003
• Combination Product (y/n): N
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 435517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 70