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

Catalog Number 5955450

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

The echo ps positioning system which is intended to be removed, was not removed from the patient during the hernia repair procedure as prescribed in the instructions-for-use.This complaint is confirmed as a use related event.A photo of the removed echo ps positioning system was provided.Based on the photo evaluation, the echo ps positioning system appears to be complete including the two mesh connectors.The surgeon indicated nothing was left in the body.As reported the ventralight st mesh was well incorporated with no problem noted.The warning section of the instructions-for-use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." the instructions-for-use also prescribes the proper method for use.Note, the bariatric surgery was being performed in a different hospital and by a different surgeon than the hernia repair procedure.Not returned.

Event Description

As reported on (b)(6) 2017 the patient underwent a hernia repair procedure during which a bard ventralight st w/ echo ps positioning system device was used for the repair.The patient was undergoing a bariatric procedure on (b)(6) 2019.During this procedure the surgeon identified an echo ps positioning system within the patients' abdomen.As reported the echo ps positioning system was, "stuck to the omentum and tranverse colon." he was able to successfully remove the complete echo ps positioning system.The surgeon reports the ventralight st mesh was well incorporated with no problem noted.The surgeon placed a drain and closed the abdomen.The surgeon was not able to then perform the scheduled bariatric procedure which has to be rescheduled.As reported that the patient was not experiencing symptoms caused by the echo ps being left in vivo.

• 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: 8436290
• MDR Text Key: 139322894
• Report Number: 1213643-2019-01809
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 5955450
• Device Lot Number: HUAX0472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR