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

Catalog Number 5955460

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fistula (1862); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The following was reported to davol: the patient was implanted with a ventralight st w/echo and a non bard/davol fixation device.During the case the doctor did not follow the prescribed method of removal and as a result a fragment of the davol inflation tube was left behind the mesh.Approximately, 3 weeks post op the patient required a procedure to repair an intestinal fistula.During the course of the procedure the previously placed mesh, and portion of the inflation assembly were explanted.As reported the root cause of the fistula formation is undetermined by the hospital/doctor.However, as reported they could not rule out the mesh or the non bard/davol fixation device as possibly contributing to the event.

Manufacturer Narrative

Based on the information available at this time, no definitive conclusions can be made.Fistula formation is listed in the ifu as a known possible complication.A review of the manufacturing records showed that this lot was manufactured with no anomalies.The malfunction related to the portion of the inflation device being left in the body was reported to fda as 1213643-2014-00403.As reported, there is no relationship between the portion of the inflation device being left in the body and the patients fistula formation.This mdr includes all patient, event and device information davol has received to date.If additional information is obtained, a follow up mdr will be submitted.

• Brand Name: VENTRALIGHT ST W/ECHO
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; cranston RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossing blvd; warwick, RI 02886 ; 8005666756
• MDR Report Key: 4278988
• MDR Text Key: 5034546
• Report Number: 1213643-2014-00411
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 5955460
• Device Lot Number: HUYD1243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 Outcome(s): Required Intervention