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

Catalog Number 5955600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the sample and root cause investigation is ongoing at this time.When the investigation is completed, a supplemental mdr will be submitted.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 august, 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.

Event Description

As reported, during use of a ventralight st w/ echo ps in umbilical hernia repair, "the fill tube for the balloon broke inside the body.¿ as reported the surgeon was ¿able to retrieve the broke loop with a grasper.¿ the mesh was able to be implanted and there was not patient injury.

Event Description

As reported, during use of a ventralight st w/ echo ps in umbilical hernia repair, "the fill tube for the balloon broke inside the body.¿ as reported the surgeon was ¿able to retrieve the broke loop with a grasper.¿ the mesh was able to be implanted and there was not patient injury.

Manufacturer Narrative

Evaluation of the sample and root cause investigation is ongoing at this time.When the investigation is completed, a supplemental mdr will be submitted.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 august, 2023.Addendum: this is an addendum to the initial mdr submitted to document sample evaluation results.Per sample evaluation: the inflation tube was returned in two pieces, with the needle loop complex intact.The yellow anchor was within the inflation assembly.Review of the tubing and the anchor shows evidence that the tubing to anchor weld had been completed.The balloon was fully inflated and no damage on device (balloon or inflation tube) was noted that would cause the balloon not to inflate.Inflation tube per condition reported did not have any impact on device inflation function.Evaluation shows the inflation tube was cut below the dashed lines, not on the dashed lines as indicated in the instructions-for-use, which could cause the inflation tube to break during device handling.There was damage found on the inflation valve and inflation tube that could be associated with excessive forces applied during use.Based on the sample evaluation and investigation performed the issue most likely presented due to incorrect handling/forces applied in use.The instructions-for-use, supplied with the device states: "once the ventra light¿ 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.Updated fields: b4, g3, g6, h2, h3, h6, h10.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 evaluated.

• 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: 18607570
• MDR Text Key: 334106578
• Report Number: 1213643-2024-00016
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5955600
• Device Lot Number: HUHS1385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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): Other