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

Model Number 31536

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

During implantation surgeon placed a tack in the middle of the device and he felt that the mesh appeared "thinner" and a hole was created in the middle of the mesh.Implantation was carried out to completion.No harm to the patient occurred.

Manufacturer Narrative

A review of the complaint details was conducted as well as an image received from the physician.The image showed that a tack had been placed in the center of the mesh that had gone through the mesh.The hole created in the mesh appears to be larger than the tack.If the tack had been placed and then the mesh manipulated it is possible that the tack was pulled through the mesh.The device history records were reviewed to ensure the product was manufactured and inspected properly.The review of the device history records indicates that the product was manufactured and inspected properly.Based on the details of the complaint and image provided, atrium medical cannot conclude that the mesh was at fault.Clinical investigation - c-qur mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (o3fa) composed of fatty acids, lipids and glycerides, coated on the monofilaments.C-qur mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.The instructions for use (ifu) instruct to inspect the mesh product for any noticeable damage to the knit construction of the mesh.Do not use a c-qur mesh that has any noticeable damage or disruption to the knit construction of the mesh as this may lead to device failure.The ifu also states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7805438
• MDR Text Key: 117880536
• Report Number: 3011175548-2018-00914
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862315363
• UDI-Public: 00650862315363
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 31536
• Device Catalogue Number: 31536
• Device Lot Number: 425424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 107