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

Catalog Number 5955450

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

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

Event Date 04/07/2022

Event Type  Injury  

Event Description

As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh was implanted using the echo ps positioning system.After closing the patient it was noted that the yellow anchor on the inflation tube of the echo ps had detached and fell into the patient.As such the surgeon reopened the patient¿s incision, located the anchor and removed it.It was reported that the surgeon did not cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use.

Manufacturer Narrative

Based on the information provided, root cause is determined to be use related.As reported, the surgeon failed to cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use (ifu).Per the ifu, 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." and "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal.Once the positioning system is verified to be fully intact, discard the echo ps¿ positioning system appropriately." by cutting the inflation tube close to the skin you are ensuring that the yellow anchor is removed from the inflation tube and discarded prior to pulling the inflation tube through the abdomen.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 november, 2020.Not returned - sample discarded.

Manufacturer Narrative

Based on the information provided, root cause is determined to be use related.As reported, the surgeon failed to cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use (ifu).Per the ifu, suppled 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." and "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal.Once the positioning system is verified to be fully intact, discard the echo ps¿ positioning system appropriately." by cutting the inflation tube close to the skin you are ensuring that the yellow anchor is removed from the inflation tube and discarded prior to pulling the inflation tube through the abdomen.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 november, 2020.Addendum: h11: this is an addendum to the initial mdr submitted to report the corrected date of event and implant.Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: b3 (date of event), b5, d.6a (medical device implant date), e1 (initial reporter e-mail) 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 - sample discarded.

Event Description

As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh was implanted using the echo ps positioning system.After closing the patient it was noted that the yellow anchor on the inflation tube of the echo ps had detached and fell into the patient.As such the surgeon reopened the patient¿s incision, located the anchor and removed it.It was reported that the surgeon did not cut the inflation tube at the skin level below the yellow anchor prior to removal as prescribed in the instructions-for-use.

• 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: 14187295
• MDR Text Key: 289876908
• Report Number: 1213643-2022-00185
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Catalogue Number: 5955450
• Device Lot Number: HUEW1688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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