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

Catalog Number 5955450

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

The sample return evaluation confirms for the breakage of the inflation tube and detachment of the yellow anchor portion of the device.Visual examination shows the material to have stretched prior to breaking.The force applied to the device in use cannot be determined at this time but appears to likely have contributed to the problem experienced.At this time a definitive root cause cannot be determined.A review of the manufacturing records has been conducted and finds the product met all specifications when released to stock.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

The following was reported to have occurred regarding a bard/davol ventralight st w/echo device during an abdominal hernia repair procedure.As the surgeon was pulling the inflation tube out of the abdomen with the suture passer, the tube separated.As reported the surgeon was pulling from the needle loop complex as normal and reported that the defect had not been closed and no scar tissue in the area.With the use of laparoscope the surgeon was able to locate the yellow anchor portion of the inflation tube lying on the bowel and used the suture passer to attempt to grab the piece but was unable to secure and it went back into the abdomen.Further search with the laparoscope, the surgeon was unable to locate the fragment.The device is not radiopaque so an x-ray could not be used to find the fragment.The surgeon then used suction and irrigation to remove the piece from the body.Once this was complete and the yellow anchor portion of the inflation tube was confirmed to have been removed.The mesh and inflation assembly components were removed from the abdomen and a new ventralight with echo device was used without issue to completed the case.As reported there was no patient injury as a result of the reported malfunction.

Manufacturer Narrative

The follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files.Corrected field: changed to (b)(4)-no known impact or consequence to 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: 5880471
• MDR Text Key: 52285408
• Report Number: 1213643-2016-00383
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Catalogue Number: 5955450
• Device Lot Number: HUAR2413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2016
• 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
• Patient Age: 33 YR