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

Catalog Number 5955450

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the echo ps inflation tube broke during removal from the patient.The inflation tube components were discarded and not available for evaluation.A photo was provided confirming a break in the inflation tube just below the yellow anchor.The needle loop complex on the upper portion of the tube remains intact and that portion of the inflation tube was likely cut prior to inflation as intended during the procedure.It appears that the user did not follow the proper steps in cutting the inflation tube close to the body below the anchor, following inflation prior to removing the echo ps balloon.As a result the anchor becoming stuck in the anatomy when pulled through and broke due to forces applied during the removal process.Based on the event as reported and the photo evaluation all portions of the inflation tube appear to have been removed from the abdomen.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 190 units released for distribution in (b)(6) 2020.The instructions-for-use provided with the device states: "once the ventralight¿ st mesh with echo ps¿ positioning system (the device) 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.Grasp the blue retrieval loop and pull the retrieval loop and inflation tube out of the abdominal cavity.To deflate the echo ps¿ positioning system, release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube.Begin pulling the positioning system off the mesh in one smooth motion.Continue removing the echo ps¿ positioning system by pulling it up to the tip of the trocar.Remove both the echo ps¿ positioning system and trocar simultaneously." should additional information be provided, a supplemental mdr will be submitted.Not returned - sample discarded.

Event Description

As reported, during a procedure on (b)(6) 2021, the bard/davol ventralight st mesh w/echo positioning system was used.As reported, while removing the echo portion, the "blue (inflation) tube broke off at the yellow (anchor) connector point with loop on the end".There was no reported patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: 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: 12491283
• MDR Text Key: 272142097
• Report Number: 1213643-2021-20334
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: 5955450
• Device Lot Number: HUEW0876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other