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

Catalog Number 5955680

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

As reported, during implant, the ventralight st w/ echo ps tubing separated and a fragment was left in-vivo.Returned for evaluation was the echo balloon and the remaining portion of the inflation tubing.Evaluation of the sample finds the inflation tube has been cut just below the needle loop complex and near the inflation assembly for removal.As reported the surgeon had closed the defect prior to attempting to pull the inflation tubing through the defect with the suture passer.Also reported was that the suture passer was not fully perpendicular coming outward.Based on the information provided and sample evaluation, the separation of the inflation tubing is likely due to stress applied, as additional force may have been needed while pulling through the closed defect at an angle that was not perpendicular.No manufacturing anomalies were found.Review of manufacturing records indicate product was manufactured to specification.The instructions-for-use supplied with the device states, ¿once the ventralight¿ st mesh with echo ps¿ positioning system (the device) is inserted into the abdomen, use a grasper to locate the blue retrieval loop on the inflation tube, ensuring that the blue inflation tube is not wrapped around the mesh and is clearly visible.Pass a suture passer device through healthy skin at the center of the hernia defect (avoid going directly through the umbilicus).Grasp the blue retrieval loop and pull the retrieval loop and inflation tube out of the abdominal cavity.Place an atraumatic clamp or hemostat on the inflation tube at the level of the skin to temporarily hold the device in place.Cut the inflation tube on the dashed line between the retrieval loop and the yellow anchor with surgical scissors to open the tube for inflation.Discard the retrieval loop.¿ sample evaluated.

Event Description

As reported, during a robotic repair procedure on (b)(6) 2020, a bard/davol ventralight st w/ echo ps was used.The defect was closed and a suture passer was placed through the center of the defect.The needle loop was grasped and as the inflation tube was being extracted, it separated.The passer was not fully perpendicular coming outward.It was noted that the separated fragment was a 1.5 mm long section of tubing that included the needle loop was left in the fascial plane.The surgeon confirmed the yellow anchor was attached to the other portion to the echo ps that was removed.The surgeon made a very small incision but the fragment was not visible and took no further action.The case was completed and there was no reported patient harm.The surgeon, an experienced user of the device advised the patient of the event and plans to take no action and does not anticipate any harm as a result of the fragment within the muscle layer.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 10977473
• MDR Text Key: 220499909
• Report Number: 1213643-2020-20070
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 5955680
• Device Lot Number: HUEQ0877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• 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