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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 5955460
Device Problems Material Separation (1562); Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  Malfunction  
Manufacturer Narrative

The sample was not returned for evaluation. However based on the events as reported the user failed to hydrate the mesh per the instructions-for-use. 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. This complaint is confirmed as use related. 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. Dhr review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components use. 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. This emdr represents ventralight st w/ echo (device #2), an additional emdr was submitted to represent ventralight st w/ echo (device #1). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.

 
Event Description

It is reported that during a robotic ventral hernia repair performed on (b)(6) 2018 the surgeon attempted to use a ventralight st w/ echo (device #1). As reported, the mesh was not hydrated, rolled with the sepra (hydrogel) barrier in, polypropylene out and inserted into the 12 mm trocar. As reported, the surgeon attempted to inflate the echo ps and the sepra coating on the mesh was sticking to itself and would not deploy properly. The surgeon then removed the mesh and another ventralight st w/ echo (device #2) was attempted to be used in the same manner. As reported, the surgeon had the same problem occur with the second device. He removed the mesh and requested another ventralight st w/ echo from a different lot and that functioned without issue. As reported, there was no patient harm/injury.

 
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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 Key7573547
MDR Text Key110346079
Report Number1213643-2018-01853
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130968
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 06/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2019
Device Catalogue Number5955460
Device LOT NumberHUBY0017
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2018
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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