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

Model Number 31537

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.[mw5086035] device not returned.

Event Description

Received medwatch mw5086035 that states "this mesh was identified as a problem as a retained surgical item".The mesh was trimmed and the clear, colorless, shiny portion of the sleeve was no longer distinguishable from the coated surface of the mesh.The absence of color or markings on the sleeve allowed the portion of the sleeve still clinging to the mesh to be implanted without detection.The patient was already in recovery by the time the error was realized by a surgical tech.The patient had to be re-intubated and had to go back under anesthesia and re-opened to obtain the mesh backing.

Manufacturer Narrative

The mesh in question was not returned for evaluation or images of the device.The lot number of the mesh was also not provided.If the mesh lot number had been provided a review of the device history records would have been conducted to ensure that the product met all quality and performance requirements.Atrium medical corporation only releases product that has met all quality and performance requirements.The details of the complaint indicate that the physician implanted the plastic sleeve that protects the mesh along with the mesh.The details also indicate that the mesh was trimmed prior to use.If the mesh was trimmed while still attached to the film it would rather obvious that the clear film was still attached to the back of the mesh.The handling sleeve facilitates ease handling in the sterile field.The plastic sleeve that protects the c-qur mesh product is loosely, but securely place around the device with a seal on each side.The sleeve visually is clear while the mesh is a tan/yellow color.The protective sleeve has a firm, smooth plastic texture while the mesh has a woven texture that is easily discernable from the packaging.The handling sleeve provides to the user tactile and visual cues that inform the user to remove it prior to implantation.The instructions for use state that ¿the atrium c-qur mesh must be removed from the handling sleeve using sterile technique prior to use.¿ summary/conclusion - based on the details of the complaint, atrium medical cannot conclude that the mesh was faulty.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8642490
• MDR Text Key: 146196055
• Report Number: 3011175548-2019-00601
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862315370
• UDI-Public: 00650862315370
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31537
• Device Catalogue Number: 31537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No
• 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