MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5991015
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the echo 2 ps portion of the ventralight st w/ echo ps 2 device was inadvertently left in the patient following mesh implant; and the patient underwent surgery for the removal for echo ps 2.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo 2 positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.It is not part of the permanent implant." review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2021.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.
Event or Problem Description
As reported per medwatch report (mw5152956): "it was incidentally noted on an x-ray, that the eps positioner for the umbilical hernia mesh used for a repair on (b)(6) 2021, was still in the patient.This is the 2nd time the failure of the surgeon to remove the eps positioner has occurred here.Is there a better design for removal of the positioner or that would not require a removable positioner? both times, the positioner was removed without incident, but did require additional surgical intervention." per information provided by customer contact: on (b)(6) 2021 patient underwent laparoscopic umbilical hernia repair with implant of ventralight st w/echo 2 positioning system and a bilateral inguinal hernia repair with mesh just prior to this procedure.On 09-feb-2024, echo 2 ps incidentally detected on x-ray and was removed without issues on 06-mar-2024 as a same day surgery.This file represents the event #1.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 19186234
• Report Number: 1213643-2024-00159
• Device Sequence Number: 17929060
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 01/28/2022
• Device Catalogue Number: 5991015
• Device Lot Number: HUFP2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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 Age: 62 YR
• Patient Sex: Male