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

Catalog Number 5955610

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

As reported one of the connectors detached from the echo ps while the user was removing it through the trocar.Photos of the echo ps were provided along with an intraoperative photo showing the connector loose in the patient's abdomen.The photo evaluation confirms detachment of one of the connectors from the echo ps.Regarding removal of the echo ps the instructions-for-use prescribes that the user remove the echo ps and trocar simultaneously.Based on the information provided and photo evaluation the echo ps connector appears to have detached from forces applied while removing the echo ps through, and not simultaneously with, the trocar as prescribed in the instructions-for-use.Regarding the removal of the balloon the instructions-for-use states, "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." a review of the manufacturing records was performed and found that the lot was manufactured to specification.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.Due to privacy laws in (b)(6), the customer has not provided any patient details.Not returned.

Event Description

It was reported that on (b)(6) 2018 a ventralight st w/ echo ps was used during a laparoscopic repair procedure.As reported while removing the echo ps through the trocar one of the connectors detached from the echo ps.It was located and retrieved from the patients abdomen.There was no harm to the patient.

• 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: 7588943
• MDR Text Key: 111159791
• Report Number: 1213643-2018-01886
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 5955610
• Device Lot Number: HUAX1302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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