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 01/08/2016

Event Type  Injury  

Manufacturer Narrative

The ifu for the ventralight st w/ echo was reviewed.Step 10 in directions for using the ventralight st w/ echo positioning system 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.Based on the events as reported, following the procedure the or staff did not verify removal of the echo ps positioning system, this complaint is confirmed as being use related with no malfunction of the device.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: it is reported that on (b)(6) 2016 the surgeon performed a laparoscopic ventral hernia repair with a bard ventralight st w/ echo.Two days later on (b)(6) 2016 the surgeon was thinking about the case and could not remember if she removed the echo balloon assembly from the mesh.On (b)(6) 2016 the surgeon took the patient back to the or and performed a laparoscopy, which confirmed that the balloon was not left in the patient.The surgeon indicated the patient is doing well at this time.

• 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: 5379485
• MDR Text Key: 36401685
• Report Number: 1213643-2016-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2016

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: 11/30/2017
• Device Catalogue Number: 5955450
• Device Lot Number: HUZJ0335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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
• Patient Age: 20 YR