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

Catalog Number 5955450

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

As reported, during a laparoscopic umbilical hernia procedure, the yellow anchor of the ventralight st echo ps became trapped under the patient¿s umbilicus when the surgeon pulled the blue retrieval loop out of patient through the umbilicus.It was reported that no anatomical difficultly (scar tissue or excessive omentum) was noted.The surgeon removed the echo ps and implanted the mesh without the use of the echo ps.The mesh was successfully implanted.There was no patient injury.

Manufacturer Narrative

As reported, the yellow anchor of the ventralight st w/echo ps detached when pulled through the umbilicus.Note the instructions-for-use instruct the user to ¿avoid going directly through the umbilicus.¿ photo provided shows a portion of the inflation tube and the detached yellow anchor in a surgical tray.Photo does not assist in determining root cause.It is reported that the sample is being returned for evaluation; however, has not been received.At this time, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2023.The instructions-for-use provided with the device state: once the ventralight st mesh with echo positioning system 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.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 : not returned.

• 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: 18958281
• MDR Text Key: 338341506
• Report Number: 1213643-2024-00098
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5955450
• Device Lot Number: HUHP0813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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