MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955680
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per voluntary medwatch report # ((b)(4)): patient had planned procedure during which mesh ventralight was placed.Patient left or (operating room) and was sent to pacu (post anesthesia care unit).During next case, surgeons realized they had left a portion of the mesh deployment device in surgical site area.Patient came back to the or to retrieve the retained foreign body.Per additional information provided in follow up: the procedure was a laparoscopic umbilical hernia repair using a ventralight st w/ echo ps.As reported, the balloon was removed from the mesh, but was not initially retrieved from the peritoneal cavity.
Additional Manufacturer Narrative
As reported, ventralight st w/echo ps balloon left inside the patient's body.Based on the information provided the reported event is determined to be use related with no malfunction of the device.Per the instructions-for-use, supplied with the device, "ventralight st mesh is the only permanent implant component of the device.The inflation adapter and syringe are to be kept external to the patient and discarded after use.The echo ps positioning system (including the balloon, all connectors, and inflation tube) must be removed from the patient and appropriately discarded.It is not part of the permanent implant" and "visualization must be maintained throughout the course of the entire procedure.Additionally, laparoscopic removal of the echo ps positioning system must be performed under sufficient visualization of the entire device and surrounding anatomy to ensure proper removal.¿ review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in dec 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.

• 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: 19477826
• Report Number: 1213643-2024-00290
• Device Sequence Number: 4071397
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2025
• Device Catalogue Number: 5955680
• Device Lot Number: HUHX0981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: Required Intervention
• Patient Sex: Male