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

Catalog Number 5955600

Device Problem Torn Material (3024)

Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

The sample was not returned to davol for evaluation. As reported during the implant procedure the balloon assembly was removed through a trocar and it was not noticed that the balloon had torn. Regarding removal of the echo ps positioning system the instructions for use (ifu) state, "begin removal of the echo ps positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard logo. Begin pulling the positioning system off the mesh in one smooth motion. Continue removing the echo ps positioning system, pulling it up to the tip of the trocar. Remove both the echo ps positioning system and trocar simultaneously. Verify that the echo ps positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps positioning system appropriately. Based on the events as reported the user did not identify the damage to the balloon assembly, which likely presented during attempted removal. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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.

Event Description

The following was reported to davol: on (b)(6) 2016 - the patient underwent the laparoscopic repair of an incisional hernia with a ventralight st w/ echo ps. On (b)(6) 2016 - the patient underwent an additional procedure due to an obstruction. During this procedure it was noted that a small piece of the balloon material (echo ps) was fused with tissues and was removed. As reported during the implant procedure the balloon was removed through a trocar and it was not noticed that the balloon had torn and a piece was left in the body. The patient is reported to have recovered.

• 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: 6124092
• MDR Text Key: 60760168
• Report Number: 1213643-2016-00538
• 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: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 5955600
• Device Lot Number: HUAP1415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/23/2016 Patient Sequence Number: 1