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

Catalog Number 5955113

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is inconclusive for the as reported condition (would not hold air) as the condition of the returned sample did not allow for identification of the reported condition. The balloon material was noted to be torn in two locations. The inflation tube was detached from the balloon assembly and not returned with the sample. The evaluation of the torn balloon material notes the material to be frayed, confirming that the material was sheared and not intentionally cut, as there would be no frayed material had the balloon been cut. The condition is consistent with what can present if the balloon assembly is pulled through the trocar to remove from the body. User confirmed to have removed the balloon from the trocar. Based on the sample evaluation and the event as reported the user removed the echo ps balloon by pulling it through the trocar not simultaneously with the trocar as prescribed in the ifu. The ifu states, 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, discard the echo ps¿ positioning system appropriately. A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution on 06/30/2016. Root cause of the torn material is use of device issue. 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 a bard ventralight st w/ echo ps was being used during a laparoscopic ipom procedure. As reported the echo ps (balloon) would not hold air during inflation. The mesh was successfully implanted without the use of the echo ps. Following implantation and fixation the echo ps was removed through a 12 mm trocar. The entire echo ps was removed from the patient, the mesh remains implanted. As reported the location of the leakage could not be identified. The hcp is reported to be an experienced user of the device and there was no injury to the patient. The sample was returned with the balloon torn in two locations and damage is consistent with what can present if the balloon assembly is removal through the trocar. All pieces were accounted for in this case. If this were to recur it is possible that a fragment could detach and go undetected or be left in the body. As such a malfunction mdr is being reported.

• 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: 6694938
• MDR Text Key: 79520383
• Report Number: 1213643-2017-00390
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 5955113
• Device Lot Number: HUAS1069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial