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

Catalog Number	5992025
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9801966
• Report Number: 1213643-2020-02155
• Device Sequence Number: 778474
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1