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

Catalog Number 5955600

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The sample is confirmed for separation of the hydrogel barrier with an unknown cause, as the contact was unable to provide information regarding how the mesh was prepared and placed.This was not reported as an out of box failure and it is unknown if the mesh was hydrated and placed as prescribed in the instructions for use.Inherently, if a dry area of the hydrogel should come in contact with a hydrated area; the dry area will pull moisture from the hydrated area causing the two sides to stick together.An attempt to separate the two sides could result in the hydrogel peeling off of one side of the mesh and sticking to the other side as was observed in the sample evaluation.The ifu states, ventralight¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.If sutures are being placed, attach the sutures to the ventralight ¿ st mesh before hydration.The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating.A minimum sized trocar is recommended for the laparoscopic delivery of ventralight ¿ st mesh.Insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis through trocar.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date there have been no other reported complaints for this manufacturing lot of 134 units released for distribution on 02/07/2017.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

Contact reported that when the surgeon attempted to use the ventralight st mesh w/ echo, the mesh stuck together instead of opening.It was removed and another used to complete the case without issue.Confirmed that there was no patient injury.Contact does not know additional information about how the mesh was prepared and placed (hydrated etc.).

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6879584
• MDR Text Key: 87859704
• Report Number: 1213643-2017-00605
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(17)190128(10)HUAZ1369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 5955600
• Device Lot Number: HUAZ1369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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