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

Catalog Number 5955450

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

As reported, during a robotic ventral hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh was implanted using the echo ps positioning system.As reported, the yellow anchor on the inflation tube detached from the inflation tube during removal of the echo ps.As reported, the surgeon searched the patient's abdomen and surgical site for 2 hours and retrieved the yellow anchor inside the patient's fascia.It was reported that the surgeon did not cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use.As reported, there was no harm or injury to the patient and the patient is doing well.

Manufacturer Narrative

Based on the information provided, root cause is determined to be use-related.As reported, the surgeon failed to cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use (ifu).Per the ifu, supplied with the device, "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." by cutting the inflation tube close to the skin you are ensuring that the yellow anchor is removed from the inflation tube and discarded prior to pulling the inflation tube through the abdomen.Review of manufacturing records confirms product was manufactured to specification.Not returned - sample discarded.

• 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: 14281929
• MDR Text Key: 290695760
• Report Number: 1213643-2022-00202
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 5955450
• Device Lot Number: HUFX0496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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): Other