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

Catalog Number 5955680

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the echo ps frame (balloon) detached from the ventralight st mesh during preparation.The subject device has been returned for evaluation.Visual evaluation of the sample finds that the mesh is unused and not hydrated.All four of the connectors are present.Three are attached to the balloon only and one is attached to the mesh and balloon.Holes in the mesh, from the connectors, indicate that the three detached connectors were at one point connected to the mesh.No manufacturing anomalies were found.Evidence shows the connectors were once attached to the mesh and align when the balloon is placed in its manufactured position.Based on the sample evaluation and investigation performed, the most probable root cause is the echo ps frame (balloon) inadvertently detached when being removed from the package during preparation for use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 237 units released for distribution in august, 2021.

Event Description

As reported, during an unknown hernia repair procedure on (b)(6) 2022, the bard/davol ventralight st mesh detached from the echo positioning system (ps) balloon prior to insertion into the patient.As reported, the surgeon used another device to complete the procedure and there was no reported patient injury.

• 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: 14014012
• MDR Text Key: 288597490
• Report Number: 1213643-2022-00133
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 5955680
• Device Lot Number: HUFU1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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