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

Catalog Number 5955810

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

Based on the events as reported, the surgeon did not remove the echo ps positioning system from the patient as prescribed in the instructions for use (ifu).This complaint is confirmed as use related with no malfunction of the device.It should be noted that when the product (bard ventralight st w/ echo ps) was placed in the hospital for another surgeon, the physician in question was offered demonstration and training.The physician declined the product specific training.The warning section of the instructions for use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." the instructions for use also prescribes the proper method for use.

Event Description

It was reported that on (b)(6) 2017 while preparing for an open ventral hernia repair procedure the surgeon¿s ¿usual mesh was unavailable in the required size¿ and the surgeon used a bard ventralight st w/ echo ps that was available in inventory for the case.The surgeon had not used, nor had she been trained to use the ventralight st w/ echo ps.The surgeon mistakenly thought the positioning balloon was a stiffening rim as she had encountered with other products and left the positioning balloon in vivo.Following the procedure the surgeon was writing up the case and at that time referred to the product information and realized the positioning balloon was intended for removal once the mesh had been secured when used laparoscopically.The surgeon reviewed the situation with her colleagues and they agreed that as the ventralight st had been placed in the pre peritoneal plane with complete peritoneal coverage and with the balloon facing the peritoneum it was reasonable to expect the balloon would not interfere with mesh adherence to the muscle wall or pose a risk to intraperitoneal structures.At this time removal surgery is not planned and the patient is being monitored.

• Brand Name: VENTRALIGHT ST W/ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6845063
• MDR Text Key: 85647140
• Report Number: 1213643-2017-00562
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786(17)180828(10)HUAU1317
• Combination Product (y/n): N
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2017

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: 08/28/2018
• Device Catalogue Number: 5955810
• Device Lot Number: HUAU1317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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 Age: 61 YR
• Patient Weight: 140