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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31105
Device Problem Device Markings/Labelling Problem
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. ".

 
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Brand NameC-QUR MOSAIC
Type of DeviceMESH, 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 Key5141869
Report Number1219977-2015-00296
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date05/27/2018
Device MODEL Number31105
Device Catalogue Number31105
Device LOT Number401313
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/09/2015 Patient Sequence Number: 1
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