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

Catalog Number	5955600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the surgeon did not cut the inflation tube at skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use.Pulling the inflation tube through the abdomen with the yellow anchor attached can lead to the yellow anchor getting caught in the anatomy.Had the user followed this instruction the yellow anchor portion of the inflation tube would have been removed prior to pulling it through the abdomen.Based on the information provided the reported event is determined to be use related as the instructions-for-use were not followed.To date there have been no other reported complaints for this lot number.Per the instructions-for-use, supplied with the device, ¿to deflate the echo ps positioning system release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube¿.Device not returned.
Event or Problem Description
As reported on (b)(6) 2022 while removing the echo ps inflation assembly following implant of the ventralight st mesh the inflation tube broke and a portion of the inflation tube which included the yellow anchor was left in the patient¿s abdomen.It was reported that the surgeon did not cut the inflation tube at the skin level below the yellow anchor prior to removing the echo ps inflation assembly.The surgeon attempted to retrieve the piece of inflation tube using a suction irrigator; however, was unsuccessful and the piece was left in vivo.

• 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: 16087310
• Report Number: 1213643-2022-00827
• Device Sequence Number: 6733427
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 07/28/2024
• Device Catalogue Number: 5955600
• Device Lot Number: HUGV0752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown