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

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 #1), an additional emdr was submitted to represent ventralight st w/ echo (device #2).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.

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.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL 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 Key: 7569169
• MDR Text Key: 110072265
• Report Number: 1213643-2018-01808
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 5955460
• Device Lot Number: HUBY0017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1