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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample evaluation finds the inflation tube broke inside the yellow anchor.The yellow anchor is found to be in the correct orientation and the weld is intact.Examination found no manufacturing anomalies on the sample returned.Based on the information provided and sample evaluation a definitive conclusion cannot be made.It is possible the inflation tube broke due to forces applied while pulling the inflation tube through the defect up to fascia.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) released for distribution in november 2022.The instructions-for-use provided with the device states, "once the ventralight st mesh with echo ps 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.
Event or Problem Description
As reported, during laparoscopic ventral hernia repair procedure a ventralight st mesh w/ echo ps was attempted to be used.When the inflation tube was pulled through the skin incision after deploying the mesh into the abdominal cavity, the inflation tube broke.The surgeon did not use the mesh and it was removed.As reported, a new mesh was provided to complete the case with no patient harm or 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: 17133509
• Report Number: 1213643-2023-00234
• Device Sequence Number: 6487368
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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: 08/28/2024
• Device Catalogue Number: 5955450
• Device Lot Number: HUGW2121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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