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

Catalog Number 5955450

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 06/23/2017

Event Type  Injury  

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 ifu.This complaint is confirmed as use related with no malfunction of the device.The warning section of the ifu states: ventralight st mesh is the only permanent implant component of the device.The inflation adapter and syringe are to be kept external to the patient and discarded after use.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 ifu also states, to deflate and remove the echo ps¿ positioning system: 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 removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard® logo.Begin pulling the positioning system off the mesh in one smooth motion.Continue removing the echo ps¿ positioning system, pulling it up to the tip of the trocar.Remove both the echo ps¿ positioning system and trocar simultaneously.Verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps¿ positioning system appropriately.The information provided by bard 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 bard.

Event Description

It was reported that on (b)(6) 2017 the patient underwent a procedure during which a bard ventralight st w/ echo ps was used.The case was completed and the surgeon went on to perform another surgery using the echo ps.It was during this second case that the surgeon could not recall having removed the balloon assembly from the patient in the earlier procedure.The patient was brought back to the o.R.And the balloon assembly was removed in full without issue.The patient was reported to be doing well and was released from the hospital on post op day three.The surgeon is reported to be experienced with the echo ps positioning system.

• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6712316
• MDR Text Key: 80010081
• Report Number: 1213643-2017-00408
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717(17)170228(10)HUAP1307
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 5955450
• Device Lot Number: HUAP1307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR