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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 Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2020
Event Type  Malfunction  
Manufacturer Narrative

Evaluation of sample shows that the separation has resulted in a void of the hydrogel barrier. The mesh was returned hydrated with sutures that had been placed during preparation prior to insertion. No manufacturing anomalies were found and there was no damage reported to the hydrogel barrier prior to attempted use of the device. It is possible that the damage to the st barrier inadvertently occurred during subsequent handling/ preparation and insertion through the 10mm trocar. Per the instructions-for-use the recommend minimum trocar size for cat # 5955600 is 12mm. Based on the available information and product evaluation the most probably root cause is inadvertent damage to the st barrier during user/ device interface while handling the hydrated mesh and deploying down the 10mm trocar. A review of manufacturing records indicate product was manufactured to specification. This is the only complaint reported to date for this manufacturing lot of (b)(4) units released for distribution in november, 2019.

 
Event Description

As reported, on (b)(6) 2020 during a laparoscopic intraperitoneal onlay mesh (ipom) procedure using ventralight st w/ echo positioning system, the mesh was hydrated 2-3 seconds prior to insertion, and was introduced through a 10mm trocar with the barrier side facing in. It was identified that following insertion the barrier peeled off, before fixating the mesh. The mesh was not implanted in the patient and the procedure was completed with another unit of the same mesh with no issues. There was no reported patient 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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10249623
MDR Text Key198081005
Report Number1213643-2020-06508
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5955600
Device LOT NumberHUDW0917
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2019
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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