MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO; SURGICAL MESH

Catalog Number 5955810

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation and is confirmed for material separation.Visual examination found the sepra portion of the mesh to have stuck and peeled away from the mesh.However, the damage appears to be use related as the contact stated that the mesh was not hydrated prior to use.Regarding preparation of the device the ifu states, "it is recommended that ventralight ¿ st mesh with echo ps¿ positioning system be completely immersed in sterile saline for no more than 1¿3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis.The ventralight ¿ st mesh with echo ps¿positioning system must be rolled immediately after hydration." a review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the event as reported and the sample evaluation, the cause of the sepra separation from the mesh appears to be use related as the mesh was not hydrated prior to insertion as prescribed in the ifu.

Event Description

It was reported that during a laparoscopic recurrent incisional hernia repair procedure using a bard ventralight st w/ echo ps, after inserting the device through a 12mm trocar and attempting to open the mesh, it was noted that the sepra coating peeled off half of the mesh and stuck to itself.As reported the mesh was not hydrated prior to insertion.There was no patient injury.Another unspecified mesh was used to complete the procedure.

• Brand Name: VENTRALIGHT ST W/ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6245102
• MDR Text Key: 64602479
• Report Number: 1213643-2017-00023
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 5955810
• Device Lot Number: HUAU1319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2016
• 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 Age: 66 YR