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

Model Number 31202

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Surgeon reported that the product was opened and soaked, then touched the patient when it came apart.Surgeon set the mesh aside and used another mesh.

Manufacturer Narrative

(b)(4).Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation: upon investigation of the returned mesh sample, it was noticed that a section of stitching around the perimeter of the patch appeared to be absent.The mesh did not look mishandled or physically adulterated (cut/torn) in any way.This defect is referred to internally as "missing stitches" where there is a void in the stitch pattern."missing stitches" is a sewing defect that can occur during setup of each sewn piece and is 100% visually inspected for in manufacturing.The setup is repeated prior to each v-patch sub-assembly being sewn, and an error in the setup of one does not relate to an error in setup of a previous or subsequent sub-assembly.This is likely an isolated incident that was not identified during 100% visual inspection following the sewing process.A lot history and sterilization records review was conducted for the lot of v-patch associated with this complaint.There were no deviations or non-conformances noted with the stitching or construction of the v-patch.The product was documented to have met all lot release criteria, including 100% visual inspection of stitching, prior to lot release.A review of our complaints show that there are no other reports of this type of defect.

• 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 ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4953313
• MDR Text Key: 15915426
• Report Number: 1219977-2015-00207
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 217489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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