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

Catalog Number UNKAA087

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

The following was reported davol by the surgeon: it was reported that after removing the balloon of a ventralight st with echo the surgeon identified that a piece of the balloon was left inside the abdomen.The surgeon stated that the piece of balloon was easily removed and there was no pt injury was a result of the situation.The event as reported created the potential for additional surgical intervention to remove the piece of balloon, or for an unintended portion of the device to be left in the body, as such an mdr is being filed to document this event.

Manufacturer Narrative

Based on information provided by the surgeon he was not removing the device as recommended in the products instruction for use.Based on what the surgeon reported he did not follow this technique when removing the balloon form the mesh.The surgeon was reminded of the proper method of removal.Removing the balloon in the mano described by the surgeon could cause damage to the balloon or cause something to fall free into the pt's abdominal cavity.

• Brand Name: VENTRALIGHT ST WITH ECHO
• Manufacturer (Section D): DAVOL, SUB C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot#1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 3893520
• MDR Text Key: 17612309
• Report Number: 1213643-2014-00036
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2014

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: UNKAA087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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