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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 5955790
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2019
Event Type  Malfunction  
Manufacturer Narrative

Confirmed for use related issue. The sample evaluation confirms sections of the hydrogel coating have stuck together. As reported 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 w/ echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement. The ventralight st w/ 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. 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 "while preparing the ventralight st mesh w/ echo ps to insert into the abdomen, the or staff rolled the mesh onto the tongs and this was inserted for placement. " as reported, the mesh would not unfurl once in the abdomen and seemed to "stick together. " this ventralight st mesh with echo ps was removed and another was used successfully to complete the case. There was no patient injury. The staff is reported to be experienced users of the device. In follow up it was reported that the mesh was not hydrated prior to inserting into the abdomen. This was a robotic case and a 12mm trocar was used.

 
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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 Key8647806
MDR Text Key146652690
Report Number1213643-2019-04406
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2020
Device Catalogue Number5955790
Device LOT NumberHUCP2449
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2018
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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