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

Model Number	31106
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted on the completion of the investigation into this event.
Event or Problem Description
When surgeon tried to pass a suture through the middle of the product, the product had a hole torn in it.
Additional Manufacturer Narrative
A review of all lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including pre-and-post-sterile seal strength testing on the packaging and fourier-transform infrared spectroscopy (ftir) and coating density testing on the cured coated panel.Ball burst, suture retention (course and wale directions), and ftir testing was conducted on the polypropylene mesh material at incoming and all acceptance criteria was also met.Clinical evaluation: the c-qur mosaic mesh is intended for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical interventional procedures requiring reinforcement with a supportive material.Complications that may occur with the use of any surgical mesh include, but are not limited to inflammation, pain and mechanical disruption of tissue.The instructions for use (ifu) states adequate mesh fixation is required to minimize post-operative complications.A product may tear during suturing if it is incorrectly sized for the planned intervention, if excessive tension exists between the mesh material and the tissue and if the suture/staples/tackers are not placed adequately.The mesh product should be shaped, sized and anchored taking into consideration the patient's posture, weight and anatomical location.In order to minimize tension at the suture line, the mesh should be sized and positioned so that it extends adequately beyond the margins of the defect.The instructions for use (ifu) advise that careful attention to suture/staple/tacker placement and spacing will help to prevent excessive tension or disruption of the mesh material or underlying tissue.The ifu states adequate mesh fixation is required to minimize post-operative complications.The fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes.

• Brand Name: C-QUR MOSAIC
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• MDR Report Key: 6383325
• Report Number: 3011175548-2017-00008
• Device Sequence Number: 443045
• Product Code: FTL
• UDI-Device Identifier: 00650862311068
• UDI-Public: 00650862311068
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/22/2019
• Device Model Number: 31106
• Device Catalogue Number: 31106
• Device Lot Number: 407066
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 124