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

Catalog Number	5955800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic incisional hernia repair procedure when the surgeon was placing the ventralight st mesh w/ echo ps, the inflation tube broke within an inch of the mesh.It was reported that the surgeon grabbed the little bit of tube that was left and placed a hemostat on it.However, the surgeon was unable to inflate the balloon due to the insufficient length of the tube.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, the ventralight st mesh w/ echo ps inflation tube broke during placement.The sample evaluation finds the inflation tube to have broken just above the balloon/mesh as alleged.Review shows deformation indicating there was contact with instruments in use (grasper, suture passer) around the break.It cannot be determined if the tube deformation occurred prior or after the tube breaking as the user stated it was grasped after the break occurred.Examination found no manufacturing anomalies.It is unknown if the user experienced any resistance while pulling the device through the defect, which may have resulted in the need to apply additional force.Based on the information provided and sample evaluation a definitive conclusion cannot be made.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 95 units released for distribution in august 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.H3 other text : sample evaluated.

• 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: 17641390
• Report Number: 1213643-2023-00317
• Device Sequence Number: 12239540
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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: 06/28/2024
• Device Catalogue Number: 5955800
• Device Lot Number: HUGU0751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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