MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair procedure, the surgeon attempted to implant a ventralight st mesh using echo ps which was deployed through a 12mm trocar.The mesh would not lay flat, and the surgeon removed the device, during the removal it was noticed that one of the blue connectors that connects the mesh to the echo balloon together was missing.Note, the or staff did not check whether the connector was present on the mesh when introduced into the patient.The patient was not taken back for additional surgery to locate the connector.A new ventralight st w/ echo mesh was used to complete the case.
Additional Manufacturer Narrative
Based on the information available and without having the sample to evaluate, no conclusions can be made.As reported it appears the user experienced difficulty deploying/placing the mesh and after removing the device noted one of the connectors was missing.It is possible due to the issues experienced by the surgeon the connector became detached while removing the echo ps and mesh from the patient.However, as the or did not check for the presence of the connector prior to the case it is unclear whether the connector is in the patient¿s abdomen.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2023.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 19042666
• Report Number: 1213643-2024-00123
• Device Sequence Number: 7223429
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: 04/28/2025
• Device Catalogue Number: 5955810
• Device Lot Number: HUHS0979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown