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

Model Number 31105

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

Marketing and regulatory were consulted about the first product complaint that it is difficult to determine laparoscopically which side of the c-qur mosaic mesh should be placed against the bowel.A decision was made to add instructions to the ifu to orient the smooth side of the mesh against the bowel when placed laparoscopically.The mosaic ifu is being updated to state the following: "it is important to orient c-qur mosaic mesh correctly for proper function.The smooth side of the mesh should be positioned facing the bowel or other visceral surfaces where minimal tissue attachment is desired." this ifu would have been with the lot reported in this file as ifu was changed.The ifu is pending fda review of 510(k) for labeling changes and was submitted 25-may-2015 - 510(k) k151386.A review of the complaints database revealed (b)(4) other report related to an incident description of this type.Clinical evaluation: difficult detecting which mesh side is used on a patient has a risk of placing the rough side and not the smooth side towards the visceral surfaces and this placement may induce adhesions.Adhesions are fibrous bands that form between tissues and organs.Adhesions form as a natural part of the body's healing process after surgery in the same way that a scar forms.

Event Description

During laparoscopic repair of a ventral hernia, mosaic coated mesh (9cm round) was inserted through the trocar.Laparoscopically, it was difficult to determine which side of the mesh was coated.The surgeon removed the mesh from the body and tried again while remembering how he inserted the mesh to determine which side is which on the screen.The patient had no complications because of this issue.

Manufacturer Narrative

C-qur mosaic mesh was reviewed for lot history and sterilization records.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier-transform infrared spectroscopy and pre & post sterile pouch peel.All raw materials met all incoming testing and inspections.The sterilization records show that all results passed.Warning 5 of the mosaic ifu states the following: "it is important to orient c-qur mosaic mesh correctly for proper function.The smooth side of the mesh should be positioned facing the bowel or other visceral surfaces where minimal tissue attachment is desired.".

• Brand Name: C-QUR MOSAIC
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03054
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5141869
• MDR Text Key: 27978589
• Report Number: 1219977-2015-00296
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/27/2018
• Device Model Number: 31105
• Device Catalogue Number: 31105
• Device Lot Number: 401313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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 Age: 56 YR