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

Catalog Number UNKAA087

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

As reported the assistant did not follow prescribed removal steps.The removal method is described in the products instruction-for-use (ifu) provided with the device.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 dark arrows adjacent to the bard ® logo.Begin pulling the positioning system off the mesh in one smooth motion.As reported the event occurred due to an error on the part of the assistant, with no malfunction of the device.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.Not returned.

Event Description

The following was reported to davol: it is reported that during a robotic ventral hernia repair using the ventralight st with echo ps, the mesh was placed and without cutting the inflation tube (as prescribed in the ifu) prior to removing the balloon assembly, the assistant pulled the echo balloon assembly with the grasper at which time the "yellow anchor" detached and became stuck behind the mesh and the abdominal wall.The surgeon removed a suture from the mesh and retrieve the anchor section of the inflation tube.The mesh was re-sutured and case completed.No additional ports were placed and there was minimal delay in the case while retrieving the piece.No other difficulties in the process/procedure were noted to have contributed to the detachment of the device.There was no patient injury.The sample was discarded by the user facility.

• 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: 5989996
• MDR Text Key: 56017850
• Report Number: 1213643-2016-00458
• Device Sequence Number: 1
• Product Code: FTL
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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