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

Catalog Number UNKAA087

Device Problem Use of Device Problem (1670)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts have been made to contact the user for additional information. As reported it appears that the prescribed removal steps may not have been followed and the inflation tube not cut correctly to facilitate removal. The method is described in the products instruction-for-use (ifu) provided with the device. The ifu it states: "to deflate the echo ps ¿ positioning system, release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube. ¿ the balloon assembly is then pulled free of the mesh and removed with the trocars. Details are limited and no conclusion can be made at this time. 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. Not returned.

Event Description

The following was reported to davol: the surgeon called to report difficulty during use of the ventralight st w/ echo. The surgeon indicated that the inflation tube was not cut and that the inflation assembly was not removed in full. She was advised that the inflation assembly is not intended to be left in vivo. Multiple attempts have been made to get additional information. As reported this event may have resulted in the need for intervention, or a possible fragment being left in the body. Details are limited at this time.

Manufacturer Narrative

This follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files. Corrected field: (b)(4).

• 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: 5864442
• MDR Text Key: 51926913
• Report Number: 1213643-2016-00376
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKAA087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 05/31/2017
• 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