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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Confirmed for use related issue. The sample evaluation confirms for the reported condition of separation of the hydrogel from the mesh. Based on the sample evaluation it appears that the mesh was not hydrated prior to insertion. If the mesh is not hydrated per the instructions-for-use, portions of the hydrogel can become hydrated by bodily fluids during insertion. When this happens the dry portion of the hydrogel barrier will to stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier. The sample evaluation found no manufacturing anomalies. Per the instructions-for-use "the ventralight st mesh with echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement. The ventralight st with echo ps positioning system must be rolled immediately after hydration. " a review of the manufacturing records was performed, no manufacturing issues associated to the reported event were found in the reviewed lot. All process steps were completed per manufacturing and inspection procedures. Product passed all required inspections at both end product and subassembly levels. There was no rework or other manufacturing abnormalities that may have contributed to this complaint. Additionally, to date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018.
 
Event Description
It was reported that during a robotic ventral hernia repair the surgeon prepared the ventralight st mesh w/ echo ps by rolling properly and inserting through a 12mm trocar port, and when the mesh unfurled for placement the surgeon noted the st portion of the mesh was "falling apart. " the mesh and the echo ps were removed entirely and a new mesh was used to complete the repair with no further issue. There was no patient injury. The surgeon is reported to be a very experienced echo user. The contact was not entirely sure if the surgeon hydrated the mesh in this particular case but did indicate it is his common practice to not hydrate the mesh prior to rolling and insertion.
 
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Brand NameVENTRALIGHT ST W/ ECHO
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 Key7970965
MDR Text Key123961045
Report Number1213643-2018-03575
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2020
Device Catalogue Number5955600
Device Lot NumberHUCP2431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2018
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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