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

Catalog Number 5955460

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

The following was reported to a davol: on (b)(6) 2014, during a surgical procedure, using a ventralight st w/ echo an unintended portion of the device was left in the body.The surgeon after fixating the mesh deflated the echo positioning balloon and attempted to pull it from the body, without having cut the inflation tube below the anchor, per the prescribed method.As a result a portion of the inflation tube got caught between the mesh and the abdomen.The surgeon chose to leave that portion of the inflation tube in place behind the mesh.They removed the remaining portion of the inflation assembly and completed the case.Approx.3-weeks later, 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.

Manufacturer Narrative

The sales representative confirmed that this was the surgeons first use of the echo inflation system.The sales rep had demonstrated the use of the product the day before the case and also just before the case.Unfortunately the surgeon did not follow prescribed removal steps.The method is described in the products instruction-for-use(ifu) provided with the device.As the surgeon failed to cut the inflation tube below the portion of the anchor tube that engages the inflator, the anchor was pulled behind the mesh where it became stuck.As was reported the fistula formation and need for surgical intervention appear to be unrelated to the problem that occurred during the implant procedure.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.; warwick RI
• Manufacturer (Section G): DAVOL INC., SUB. C.R. BARD, INC.; san geronimo industrial park; lot#1, road#3, km 79.7; humacao 0079 1
• Manufacturer Contact: laura berg ; 100 sockanossett crossroad; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4250243
• MDR Text Key: 5105248
• Report Number: 1213643-2014-00403
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/10/2014
• Initial Date FDA Received: 11/06/2014
• 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