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

Catalog Number 5955460

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

Patient Problems Anxiety (2328); Injury (2348)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

The echo ps positioning system which is intended to be removed from the abdomen, was not removed from the patient during the procedure as prescribed in the instructions-for-use.This complaint is confirmed as a use related event with no malfunction of the device.The warning section of the instructions-for-use states: "ventralight st mesh is the only permanent implant component of the device.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 instructs the user to, "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal." once the positioning system is verified to be fully intact discard the echo ps¿ positioning system appropriately." not returned.

Event Description

The following was reported via maude event report mw5091719: "during the repair of umbilical hernia, ((b)(6) 2019) the echo ps positioning system ventralight mesh was used.The patient went home and was called back the next day as the surgeon suspected it was not removed.This balloon is not detectable on any imaging including x-ray, ct, or mri.An exploratory surgery needed to be performed ((b)(6) 2019).The balloon portion was left inside the patient.If there was an imaging marker on, the patient would have been taken imaging and not directly to surgery." in follow up with customer contact it is reported that the surgeon is an experienced user of the device and the patient has recuperated, however has anxiety.

• 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: 9578292
• MDR Text Key: 188794881
• Report Number: 1213643-2020-00245
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 5955460
• Device Lot Number: HUCZ0789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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