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 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned to davol for evaluation, therefore no definitive conclusions can be made at this time.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." a review of the manufacturing records was performed and found that the lot was manufactured to specification.The 3500a form reported that the device was available for return; multiple attempts have been made to secure the return of the sample for evaluation, however to date the sample has not been returned to davol.

Event Description

The following was reported to davol by the fda via medwatch 3500a report: (b)(4).Surgeon tacked mesh to abdominal wall with absorbable tacks, removing echo ps positioning system from tacked mesh by pulling in normal fashion.The echo ps positioning system was delivered through a 12mm operative port with laparoscopic grasper.While doing, surgeon discovered that a piece (approx.4.5cm x 2cm) tore from the main body of the echo positioning framework landing on the mesentery.Retrieval was done by surgeon immediately, with laparoscopic instrument.The torn piece was compared to the missing area on the main body of the positioning system (previously delivered) and determined by the surgeon that the entire torn piece was removed successfully causing 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6083552
• MDR Text Key: 59361490
• Report Number: 1213643-2016-00509
• 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: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 5955600
• Device Lot Number: HUZK0663
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2015
• 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 Age: 38 YR
• Patient Weight: 133