MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number 5955450

Device Problem Improper or Incorrect Procedure or Method (2017)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

As reported, during a robotic ventral hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh w/echo positioning system was implanted in the patient using the introducer tool.It was reported that the surgeon inflated the echo ps as directed without any issue and the mesh was fixated.As reported, when the surgeon attempted to remove the echo ps, the inflation tube broke and it was noted that a piece of the inflation tube with the yellow anchor was stuck inside the patient's fascia.It was reported that the surgeon forgot to cut the inflation tube at the skin level below the yellow anchor prior to removal.As reported, the surgeon managed to locate the inflation tube and yellow anchor and removed it from the patient.The case was completed without any further issues.There was no reported patient injury.

Manufacturer Narrative

As reported, following implant of the ventralight st mesh, when the surgeon attempted to remove the echo ps from the patient¿s abdomen, the inflation tube broke and it was noted that a piece of the inflation tube with the yellow anchor was stuck inside the patient's fascia.The surgeon identified he forgot to cut the inflation tube at the skin level below the yellow anchor prior to removal.Photos provided show that this resulted in the inflation tube breaking below the yellow anchor while being pulled back through the anatomy.The yellow anchor remains attached to the broken piece of tubing.The product instructions-for-use instructs on cutting the inflation tube at the skin level (below the anchor point), which ensures that the portion of the inflation tube containing the yellow anchor is removed prior to pulling it out through the abdomen.Based on the photo evaluation and information provided, the root cause of the inflation tube break is use related as a result of pulling the inflation tube and yellow anchor back through the patient anatomy and not cutting the tube at skin level during the removal process.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use, supplied with the device states, "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." and "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.".

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 13769067
• MDR Text Key: 288394529
• Report Number: 1213643-2022-00064
• 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
• Reporter Occupation: Nurse
• Report Date: 03/02/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: 5955450
• Device Lot Number: HUFW2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial