MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALISHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number 5991015

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

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

Based on the events as reported the echo 2 ps was not removed from the patient as prescribed in the instructions-for-use.The root cause is confirmed as use related 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 2¿ positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.It is not part of the permanent implant.Sample not returned.

Event Description

It was reported that on (b)(6) 2019 the patient underwent a robotic assisted laparoscopic ventral incisional hernia repair with a ventralight st w/ echo 2 ps.The surgeon later realized he had not removed the echo 2 ps portion of the device from the implant.On (b)(6) 2019 the patient underwent a laparoscopic procedure for removal of the echo 2 ps.As reported the procedure was uncomplicated.

• Brand Name: VENTRALISHT ST W/ ECHO 2
• 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: 8568633
• MDR Text Key: 143676864
• Report Number: 1213643-2019-03534
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5991015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Weight: 97