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

Catalog Number	5955450
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a ventralight st w/ echo ps was used during a laparoscopic ventral hernia repair procedure on (b)(6) 2024.It was reported that the yellow anchor of ventralight st w/ echo ps detached and fell into the patient.It was also reported that yellow anchor was retrieved and the procedure was completed.There was no patient injury.
Additional Manufacturer Narrative
As reported, the yellow anchor from the ventralight st echo ps detached, fell into patient, and was retrieved.Returned for evaluation was the detached yellow anchor.The inflation tubing, and balloon were not included with the return.Evaluation of the returned sample finds no tubing remaining within the anchor as it has detached in full, from the tube.Weld marks (indents) are present indicating the anchor was welded onto the tubing.Based on the event reported and not having the complete sample returned for evaluation, a definitive conclusion cannot be made.However, it is likely the anchor detached due to forces applied while in use.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 189 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.
Additional Manufacturer Narrative
As reported, the yellow anchor from the ventralight st echo ps detached, fell into patient, and was retrieved.Returned for evaluation was the detached yellow anchor.The inflation tubing, and balloon were not included with the return.Evaluation of the returned sample finds no tubing remaining within the anchor as it has detached in full, from the tube.Weld marks (indents) are present indicating the anchor was welded onto the tubing.Based on the event reported and not having the complete sample returned for evaluation, a definitive conclusion cannot be made.However, it is likely the anchor detached due to forces applied while in use.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.Updated fields: a2 (age at time of event), a3, b4, g2, g3, g6, h2, h3, h10, h11 corrected field: e4.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, a ventralight st w/ echo ps was used during a laparoscopic ventral hernia repair procedure on (b)(6) 2024.It was reported that the yellow anchor of ventralight st w/ echo ps detached and fell into the patient.It was also reported that yellow anchor was retrieved, and the procedure was completed.There was no patient injury.

• 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: 19937844
• Report Number: 1213643-2024-00394
• Device Sequence Number: 4876952
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717(17)260128(10)HUJP1120
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 5955450
• Device Lot Number: HUJP1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: 54 YR
• Patient Sex: Female