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

Catalog Number	5955810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the positioning frame of the ventralight st w/ echo mesh detached during placement.The sample was not returned for evaluation.Based on the information provided, and not having the sample to evaluate, root cause for the reported event could not be determined; no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2019.The instructions for use (ifu) supplied with this device recommends " the ventralight st mesh with echo ps positioning system should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.The ventralight st with echo ps positioning system must be rolled immediately after hydration.Using the introducer tool or grasper roll the ventralight st mesh with echo ps positioning system parallel to the bard logo with the polypropylene on the outside and bioresorbable coated side with the echo ps on the inside.Insert into the abdomen through the recommended minimum trocar or trocar incision site.Do not force the device through the trocar.If the ventralight st mesh with echo ps positioning system will not easily deploy down the trocar, remove the trocar and insert through the next largest available size trocar or through the trocar incision site and reinsert trocar.See table in product description section for recommended minimum trocar size." per the instructions-for-use the recommended minimum trocar size for cat # 5955810 is 12mm.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
It was reported that during a laparoscopic abdominal ventral hernia repair procedure on (b)(6) 2020, ventralight st mesh w/ echo positioning system (8x10, ellipse) was used.During placement of the mesh through a 12mm trocar, the echo ps balloon detached from the mesh after inflation.As reported, the surgeon worked around the issue and was able to fixate the mesh and the mesh was successfully implanted.However, as reported ¿it caused the process to become more difficult with placement.¿ there was no reported patient injury and the surgeon is an experienced user of the device.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10678295
• Report Number: 1213643-2020-09365
• Device Sequence Number: 2590940
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 07/28/2021
• Device Catalogue Number: 5955810
• Device Lot Number: HUDV1937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1