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

Catalog Number 5955810

Device Problems Detachment Of Device Component (1104); Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The following was reported to davol: it was reported that while attempting to position a ventralight st w/echo device the balloon would not inflate.While the surgeon continued to move the mesh to assist in the inflation process the balloon detached from the mesh.The surgeon removed the mesh and balloon and used another of the same device to complete the case without issue.The surgeon is an experienced user of the device and was using proper technique.

Manufacturer Narrative

No conclusion can be made at this time.The device was discarded following the procedure and therefore unavailable for evaluation.The facility did return the outer box and mesh package, which did not assist in the investigation.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.A review of our complaint records shows this to be the only reported complaint for this lot.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): BARD SHANNON LIMITED; lot #1, road #3, km. 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4286350
• MDR Text Key: 5228214
• Report Number: 1213643-2014-00415
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

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 Expiration Date: 02/29/2016
• Device Catalogue Number: 5955810
• Device Lot Number: HUYB0394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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