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

Model Number 31202

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Hospital reported they received a unit with a twisted ring and would not lay flat.Procedure was open umbilical hernia repair.

Manufacturer Narrative

A review of lot history and sterilization records was performed.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre and post sterile pouches.All raw materials met all incoming testing and inspections.Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release.The inspection of the mesh revealed several areas of coating delamination although the stitching around the perimeter was intact.The ring in the center of the device was intact, the correct size and laid flat.Consequently, the c-qur v-patch mesh sample was still conforming and would have been acceptable for use.When the product was returned the ring was lying flat.Due to limited information provided, the cause of the complaint cannot be determined.Clinical evaluation: when a procedure is planned and preparations are made, the required product is introduced to the procedure table prior to the start of the procedure.Product, expiration date, size and sterility/package integrity are inspected and confirmed with two clinicians at that time.If there was a defect in the product it would be noticed at that time and a replacement would be located.This would represent a delay for the patient who is confined to an operating table and under sedation or anesthesia, increasing the risk of immobility and prolonged sedation time.The complaint states that the ring of the mesh was twisted and would not lay flat.A product is used or discarded at the discretion of the physician.A defective product is not expected to be used in a procedure.The instructions for use warn, please inspect packaging to ensure it is intact and not damaged prior to use.

• Brand Name: C-QUR V-PATCH
• 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: 5636787
• MDR Text Key: 44589126
• Report Number: 1219977-2016-00092
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312027
• UDI-Public: 00650862312027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 203053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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: 71 YR