MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number 5992025

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Based on the events as reported the mesh was hydrated and the or staff and surgeon were unable to successfully deploy the mesh down the trocar with multiple attempts.It was noted after 5-10 minutes of mesh handling that the barrier of the device was scraping off.Sample evaluation confirms the hydrogel had begun to ball up and scrap off the mesh.The sample evaluation confirms the hydrogel had not completely detached from the mesh and did not create any voids.The sample evaluation finds no manufacturing anomalies.Over-handling after hydration of the mesh can result in the condition found.Additionally, it is unknown how long the mesh had been hydrated for and if the mesh was rolled without delay following hydration, damage to the hydrogel can occur if the mesh is hydrated longer than the 1-3 seconds and not rolled immediately following hydration as prescribed in the instructions-for-use.Based on the event as reported and condition of the mesh sample, the separation of the hydrogel is most reasonably the result of over-handling (5-10 mins) during user/ device interface.Per the instructions-for-use, "ventralight st mesh with echo 2 positioning system should be hydrated for no more than 1-3 seconds and must be rolled immediately after hydration to maximize the flexibility of the prosthesis.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in december, 2019.

Event Description

As reported during a robotic flank hernia procedure on (b)(6) 2020, the surgeon who is a first time user of the bard ventralight st w /echo 2, noted after 5-10 minutes of mesh handling that the barrier of the device was scraping off.Customer reports that the mesh was hydrated prior to use.As reported a 12mm trocar was being used in the field, but the "mesh techs and surgeon were unable to get the mesh down the trocar and they tried a few different times.".

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 9801966
• MDR Text Key: 183292301
• Report Number: 1213643-2020-02155
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 5992025
• Device Lot Number: HUDX0818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2019
• 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