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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As per medsun voluntary report #(b)(4)."extra-gynecological surgical mesh composite polymer patient had laparoscopic hernia repair surgery on (b)(6) 2024.Today dr.(b)(6) stated he could not remember removing positioning balloon from mesh.Patient scheduled for diagnostic laparoscopy to verify if balloon was retained.Laparoscopy performed; balloon identified still attached to mesh on abdominal wall.Balloon retrieved and sent to lab for gross id.What was the original intended procedure? mesh implanted.What problem did the user have: not known.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known;".
Additional Manufacturer Narrative
As reported, ventralight st w/echo ps balloon was left inadvertently inside the patient's body following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device.Review of manufacturing records confirms product was manufactured to specification.The instructions-for-use, supplied with the device states, ¿ventralight¿ st mesh is the only permanent implant component of the device.The inflation adapter and syringe are to be kept external to the patient and discarded after use.The echo ps¿ positioning system (including the balloon, all connectors, and inflation tube) must be removed from the patient and appropriately discarded.It is not part of the permanent implant." and ¿visualization must be maintained throughout the course of the entire procedure.Additionally, laparoscopic removal of the echo ps¿ positioning system must be performed under sufficient visualization of the entire device and surrounding anatomy to ensure proper removal.¿ 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: 20404588
• Report Number: 1213643-2024-00485
• Device Sequence Number: 12382045
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717(17)250728(10)HUHV0932
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2025
• Device Catalogue Number: 5955450
• Device Lot Number: HUHV0932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male