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

Catalog Number 5955460

Device Problems Crack (1135); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

The sample evaluation confirms as was reported that the mesh had not been hydrated.The evaluation shows evidence that the mesh was rolled with the hydrogel barrier facing out.The instructions-for-use prescribe that the user,"hydrate the device for no more than 1¿3 seconds just prior to rolling." and to, "roll the device tightly on itself starting at the edge parallel to the bard® logo and continue across with the polypropylene side on the outside and bioresorbable (hydrogel) coated side with the echo ps¿ positioning system on the inside." visual examination confirms cracks noted in the hydrogel barrier.This condition can present if the material is not hydrated as recommended.This complaint is confirmed for use related as the damage to the hydrogel barrier was due to the mesh being rolled not hydrated with the barrier facing out.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 was reported that on (b)(6) 2018 a bdi surgery / davol ventralight st w/ echo device was being used during a robotic laparoscopic ventral hernia repair.As reported the mesh was noted to be "splitting" after being inserted into the patient.In follow up with the contact it was reported that the mesh was not hydrated prior to being rolled for insertion and was rolled with the sepra barrier (hydrogel) facing in.It was after the mesh was placed into the abdomen the surgeon noticed the "sepra barrier was coming off." the mesh was removed and another was used to complete the case without further issue.

• 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: 7395147
• MDR Text Key: 104415641
• Report Number: 1213643-2018-00882
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 5955460
• Device Lot Number: HUAY1799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• 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