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

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received report that during a laproscopic hernia surgery the mesh ripped when the doctor was trying to fixate the mesh using a protack fixation device.

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.The instructions for use states the following "the fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes." it further states "careful attention to suture, staple, and/or tack placement and spacing will help prevent excessive tension or disruption of the mesh material and/or underlying tissue.It is recommended that sutures, staples, and/or tacks be placed a minimum of 6.5 mm from the edge of the mesh and spaced 2 cm apart from each other for best results." in addition, each incoming lot of mesh is tested for strength on an instron with both suture retention and ball burst tests.Clinical evaluation: the mesh may tear as a result of a technical error, improper suture fixation and incorrect sizing which will cause stress and tension of the mesh.Important aspects of user experience include the necessity of having operative planning with full identification of the extent of the hernia, adept skills in the application of sutures/tacks, and reconstruction skills assuring closure of the wound in layers and coverage of the implanted mesh with minimal space for serous collections and no direct pathway to the mesh from the skin.The instructions for use instructs that mesh products should be shaped, sized and anchored taking into consideration the patient's posture, weight and anatomical location.In order to minimize anchor disruption the mesh should be sized and positioned so that it extends adequately beyond the margins of the defect.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5220830
• MDR Text Key: 31047694
• Report Number: 1219977-2015-00328
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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