MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH; SURGICAL MESH

Catalog Number 0010212

Device Problems Hole In Material (1293); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As reported the user experienced difficulty when attempting to insert the device into the trocar.It is not known what size trocar was used.Multiple attempts were made to gather more information but there was no response to our request to date.The instructions-for-use state, "for laparoscopic procedures, all size patches should be rolled into thirds along the long axis, eptfe side out, and inserted through a trocar site which is a minimum of 12mm (remove trocar, insert mesh, and reinsert trocar)." visual examination of the returned samples confirms the report that the user attempted to place the mesh, based on physical condition.Multiple device interface marks are present and it appears that a grasper was used during attempted insertion.The forces applied to the device during the attempted implantation appear to have caused a hole to present in the eptfe layer.This was not reported as an out of the box condition and no manufacturing issues were noted during the sample evaluation.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2017.Based on the sample evaluation it appears that the damage to the device was due to user/device interface inadvertently damaging the implant.No manufacturing or material anomalies were found.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

As reported the user experienced difficulty when attempting to insert the bard ventrio hernia patch into the trocar of the coelioscopy.There was no patient adverse outcome reported as a result of this event.The sample was returned to davol and the evaluation noted a hole in the eptfe layer which appears to have been made during attempted insertion into the trocar.A hole in the eptfe layer could impact the ability of the device to perform as intended if used, and could increase the risk of post operative complications and adhesion formation as such an mdr is filed to document this event.

• Brand Name: VENTRIO MESH
• 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: 7025891
• MDR Text Key: 92863955
• Report Number: 1213643-2017-00847
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (y/n): N
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 0010212
• Device Lot Number: HUAY2591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 86