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

Catalog Number	5990011
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided no conclusion can be made.The sample has not been returned for evaluation and the information provided is limited.Multiple requests for additional information and sample return have been made.To date this is the only reported complaint for this production lot of (b)(4) released for distribution in april, 2019.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided or the sample is returned for evaluation, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
As reported per customer contact: when the surgeon went to implant a bard ventralight st w/ echo 2 ps the device separated and was unable to be used.As reported, to complete the case a replacement item was used and there was no impact or injury to the patient.
Additional Manufacturer Narrative
Based on the information provided no conclusion can be made.The sample has not been returned for evaluation and the information provided is limited.Multiple requests for additional information and sample return have been made.To date this is the only reported complaint for this production lot of 145 released for distribution in april, 2019.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided or the sample is returned for evaluation, a supplemental emdr will be submitted.This is an addendum to the initial emdr to document additional information and the receipt and evaluation of the sample.Per the instructions-for-use, provided with the device after rolling the device 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." in follow up it is reported that the surgeon rolls the mesh and grabs onto the echo frame only and not both mesh and frame as instructed in the instructions-for-use, prior to inserting the device down the 12mm trocar.Grabbing only the echo frame and not both the mesh and frame, could cause the frame to detach from the mesh during deployment.The most probable root cause is determined to be use related.The sample evaluation confirms the mesh is detached from the echo frame as reported.The sample evaluation shows no manufacturing anomalies with the device.
Event or Problem Description
As reported per customer contact: when the surgeon went to implant a bard ventralight st w/ echo 2 ps the device separated and was unable to be used.As reported, to complete the case a replacement item was used and there was no impact or injury to the patient.

• Brand Name: VENTALIGHT 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: 9005598
• Report Number: 1213643-2019-08665
• Device Sequence Number: 14136873
• 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: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10/25/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1