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

Catalog Number	5990011
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause is most likely determined to be use related.The sample was returned for evaluation.The sample was returned in good condition and found no manufacturing anomalies.Based on the sample condition there is no indication the device was defective out of the box.The device was being manipulated for placement as indicated by the mesh being returned hydrated and contaminated with blood.One (1) of the five (5) connectors was found to be broken.One (1) connector breaking would not result in the frame detaching from the mesh.It is likely that the broken connector is a result of forces applied while inserting and pulling the device through the trocar during placement.Similar complaints (3) have been reported by the same surgeon a review of those complaints noted that the surgeon rolls the mesh and grabs onto the echo frame only, prior to inserting the device down the trocar, therefore causing the detachment to present.Based on the product evaluation and information provided the echo 2 frame detaching and connector breaking from the mesh during deployment is the result of the placement technique and forces used during user/device interface.Following the three (3) initial complaints an in-service training was provided to the doctor and facility to demonstrate per the instructions-for-use, the proper way to insert the device through the trocar.Per the instructions-for-use the user is instructed to "grasp the leading edge of the device with an atraumatic grasper or grasping tool.Take care to grasp both mesh and frame material." note by grabbing only the echo frame and not both the mesh and the frame, can cause the frame to detach from the mesh.Based on the information provided, the sample evaluation and the history of this type of issue presenting for this surgeon, the root cause is determined to be use related.
Event or Problem Description
It was reported that on (b)(6) 2019, during a laparoscopic umbilical hernia repair, a bard ventralight st w/ echo 2, was "defective and the piece detached prior to use with the patient." as reported, there was no injury or impact to the patient and the case was completed with the use "of a different item.".

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9465954
• Report Number: 1213643-2019-12122
• Device Sequence Number: 11532647
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 5990011
• Device Lot Number: HUCY0647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1