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

Catalog Number 5955460

Device Problems Break (1069); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

The sample was not returned for evaluation.The instructions for use, provided with the device, prescribe the following steps when removing the echo ps ¿ positioning system.Steps 9 and 10 state "to deflate the echo ps ¿ positioning system, release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube.¿ begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by dark arrows adjacent to the bard ® logo.Begin pulling the positioning system off the mesh in one smooth motion." based on the events as reported the surgeon failed to follow the instructions-for-use and did not "cut the inflation tube as close to the skin as possible", which would have ensured that the portion of the inflation tube that contained the anchor would have been cut off and discarded.Not returned.

Event Description

It was reported that a bard ventralight st w/ echo ps device was being used during a procedure on (b)(6) 2017.As reported the surgeon did not cut the inflation tubing at the level of the skin (as instructed in the ifu) and was pulling the device out of the abdomen when it was noted the "yellow anchor" had become detached.The surgeon did a visual inspection but could not find the anchor and reported he suspects it may have become caught in the adipose tissue in the abdomen.As reported, the patient has an abundant amount of adipose tissue in which the anchor and tubing was being pulled through at the time the event occurred.No additional incisions were made and the surgeon decided to close the patient and treat with antibiotics.As reported, there is no plan for additional medical or surgical intervention at this time and the anchor was left in vivo.Patient is not exhibiting any ill effects.The surgeon is not a frequent user of the echo ps device.

• 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: 7175199
• MDR Text Key: 96752766
• Report Number: 1213643-2018-00034
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (y/n): N
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 5955460
• Device Lot Number: HUBS0280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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