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

Catalog Number	5955460
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a robotic ventral hernia repair on (b)(6) 2024, while the ventralight st mesh w/ echo ps inflation tube was being pulled up through the skin incision the inflation tube broke, and the yellow anchor detached.It was reported that the piece of tubing with the yellow anchor were found stuck in between the skin.The piece of tubing and anchor were retrieved.The procedure was completed using the same mesh and there was no patient injury.
Additional Manufacturer Narrative
The inflation tube was returned in two pieces along with the detached yellow anchor.Review of the tubing and the anchor shows evidence that the tubing to anchor weld had been completed.The break in the inflation tube is visibly jagged consistent with the material tearing while being pulled through the incision.Based on the inflation tube condition the most probable root cause is the inflation tube met resistance in the subcutaneous fat while being pulled through the incision.Forces applied pulling the inflation tube through resulted in the tube break and anchor detachment.No manufacturing anomalies were found.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 april 2024.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 or Problem Description
As reported, during a robotic ventral hernia repair on (b)(6) 2024, while the ventralight st mesh w/ echo ps inflation tube was being pulled up through the skin incision the inflation tube broke, and the yellow anchor detached.It was reported that the piece of tubing with the yellow anchor were found stuck in between the skin.The piece of tubing and anchor were retrieved.The procedure was completed using the same mesh and there was no patient injury.
Additional Manufacturer Narrative
The inflation tube was returned in two pieces along with the detached yellow anchor.Review of the tubing and the anchor shows evidence that the tubing to anchor weld had been completed.The break in the inflation tube is visibly jagged consistent with the material tearing while being pulled through the incision.Based on the inflation tube condition the most probable root cause is the inflation tube met resistance in the subcutaneous fat while being pulled through the incision.Forces applied pulling the inflation tube through resulted in the tube break and anchor detachment.No manufacturing anomalies were found.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 april 2024.Addendum: h11: this supplemental mdr is submitted to document the information provided through medsun report.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.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: 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: 20472781
• Report Number: 1213643-2024-00505
• Device Sequence Number: 20721769
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724(17)260128(10)HUJP1156
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2026
• Device Catalogue Number: 5955460
• Device Lot Number: HUJP1156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Unknown