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

Catalog Number 5955600

Device Problems Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The balloon assembly was returned for evaluation and is confirmed for a small portion of the balloon to be detached from the rest of the balloon.Inspection of both pieces confirms that the entire balloon was removed from the patient.Visually evaluation of the echo ps balloon finds that the balloon material likely experienced a shear force during removal.It appears the user inadvertently sheared off a section of the balloon material while removing the device through the trocar, resulting in the damage that presented.As reported the balloon was pulled through the trocar during removal.The instructions for use, which are supplied with the device, prescribe that the balloon be removed simultaneously with the trocar, not pulled through the trocar, stating, "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 of the mesh in one smooth motion.Continue removing echo ps" positioning system and trocar simultaneously." based on the event as reported and the sample evaluation the surgeon did not follow the prescribed technique for the removal of the echo ps " positioning system, which may have put additional stresses on the balloon resulting in the observed damage.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.Not returned.

Event Description

The following was reported to davol.On (b)(6) 2016 following a successful implant of a ventralight st mesh with echo, while removing the balloon through a 12mm trocar the balloon tore into two pieces.The balloon was inflated with no issued.All pieces were removed from the body.There was no injury 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6100230
• MDR Text Key: 59863553
• Report Number: 1213643-2016-00517
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 5955600
• Device Lot Number: HUAT1335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2016
• 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