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	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
As reported, the yellow anchor of the ventra light 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 ventra light 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.Addendum: this is an addendum to the initial mdr submitted to document the result of sample evaluation.Evaluation of the returned echo ps assembly and detached yellow anchor was conducted.The evaluation finds the inflation tube had been cut in two places indicating the inflation tube was cut during use and the removal process.However, a portion of the inflation tube was not returned with the device.Based on not having the entire inflation tube returned for review a definitive conclusion as to the cause of the anchor detachment cannot be made.However, it is possible the anchor detached due to forces applied while pulling the inflation tube through the umbilicus.Per the instructions-for-use, supplied with the device, instructs the user to avoid going directly through the umbilicus.Our records continue to show there have been no other reported complaints to date for this lot.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 : sample evaluated.
Event or Problem Description
As reported, during a laparoscopic umbilical hernia procedure, the yellow anchor of the ventra light 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.

• 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: 18958281
• Report Number: 1213643-2024-00098
• Device Sequence Number: 9345973
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 01/28/2025
• Device Catalogue Number: 5955450
• Device Lot Number: HUHP0813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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: Other
• Patient Sex: Unknown