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

Catalog Number 5955450

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

Based on the events as reported, the surgeon did not follow the instructions for removal as prescribed in the ifu.Step 10 states "begin removal of the echo ps positioning system by pulling it up to the tip of the trocar.Remove both the echo ps positioning system and trocar simultaneously.The ifu also notes the user should verify that the echo ps positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal.As reported the event was user related and there was no device malfunction.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.Not returned.

Event Description

The following was reported to davol: on (b)(6) 2016 during a ventral hernia repair while using a bard/davol ventralight st with echo ps the surgeon cut the inflation tube and removed the balloon assembly from the mesh, and placed it in the abdomen.He then had to tend to something else and forgot to remove the balloon assembly from the body.After closing the patient, but before leaving the o.R.The surgeon remembered he did not remove the inflation balloon so he reinserted his laparoscope and trocars and then removed the inflation balloon without any difficulty or injury to the patient.

Manufacturer Narrative

This is an addendum to the initial mdr to make a correction to the 510k number that was reported on the initial mdr.

• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5467214
• MDR Text Key: 39256820
• Report Number: 1213643-2016-00076
• Device Sequence Number: 1
• Product Code: FTL
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 5955450
• Device Lot Number: HUZI1271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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 Outcome(s): Required Intervention