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

Catalog Number 5955610

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

As reported one of the connectors detached from the balloon while being removed through the trocar.The sample evaluation confirms detachment of one of the connectors from the balloon.Regarding removal of the balloon the ifu prescribes that the user remove the balloon and trocar simultaneously.Based on the information provided and product evaluation the balloon connector appears to have detached from forces applied while removing the balloon through and not simultaneously with the trocar as prescribed in the ifu.Regarding the removal of the balloon the ifu states, "begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard® logo.Begin pulling the positioning system off the mesh in one smooth motion.Continue removing the echo ps¿ positioning system, pulling it up to the tip of the trocar.Remove both the echo ps¿ positioning system and trocar simultaneously.Verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps¿ positioning system appropriately." no lot number has been provided; therefore a review of the manufacturing records could not be performed.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.Due to privacy laws in (b)(4), the customer has not provided any patient details.

Event Description

It was reported that on (b)(6)2017 a bard ventralight st w/ echo ps was being used during a procedure.As reported during the process of removing the balloon through a 15mm port/trocar one of the connectors detached from the balloon and was retrieved from the patient¿s abdomen.There was no injury to the patient.

Manufacturer Narrative

This is an addendum to the initial mdr to document that the lot number has been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 64 units released for distribution on 11/30/2016.

• 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: 6803875
• MDR Text Key: 83105000
• Report Number: 1213643-2017-00515
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (y/n): N
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 5955610
• Device Lot Number: HUAX1302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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