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

Catalog Number 5990011

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

As reported, the echo 2 ps portion of the ventralight st w/ echo 2 ps was inadvertently left in the patient following mesh implant; the patient was taken back to the or and the portion was removed.No additional complications were reported.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 the device, ¿ventralight¿ st mesh is the only permanent implant component of the device.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.¿ "verify that the echo 2¿ positioning system frame is fully intact after removal, including all components listed (echo 2¿ positioning frame, connectors, suture) and discard appropriately." 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 : sample not returned.

Event Description

As per medwatch form, "patient to the or for ra (operating room for regional anesthesia) laparoscopic incisional umbilical hernia repair with bard 11.4cm ventralight mesh.While patient was in pacu (post-anesthesia care unit,), it was realized that the scaffold was not removed from the mesh during the initial procedure.Patient was taken back to the operating room for a diagnostic laparoscopy.The echo 2 scaffolding was identified and removed with luq (left upper quadrant) trochar.The physician carefully examined the scaffolding and it was determined to be intact.".

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Type of Device: 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: 17867824
• MDR Text Key: 324877590
• Report Number: 1213643-2023-00356
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: 5990011
• Device Lot Number: HUGT0811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention