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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
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. ".

 
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Brand NameVENTRALIGHT ST W/ ECHO 2
Type of DeviceSURGICAL 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 Key9801966
MDR Text Key183292301
Report Number1213643-2020-02155
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK170294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 03/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2020
Device Catalogue Number5992025
Device LOT NumberHUDX0818
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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