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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955460
Device Problems Break (1069); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2017
Event Type  Injury  
Manufacturer Narrative
The sample was not returned for evaluation. The instructions for use, provided with the device, prescribe the following steps when removing the echo ps ¿ positioning system. Steps 9 and 10 state "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. ¿ begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by dark arrows adjacent to the bard ® logo. Begin pulling the positioning system off the mesh in one smooth motion. " based on the events as reported the surgeon failed to follow the instructions-for-use and did not "cut the inflation tube as close to the skin as possible", which would have ensured that the portion of the inflation tube that contained the anchor would have been cut off and discarded. Not returned.
 
Event Description
It was reported that a bard ventralight st w/ echo ps device was being used during a procedure on (b)(6) 2017. As reported the surgeon did not cut the inflation tubing at the level of the skin (as instructed in the ifu) and was pulling the device out of the abdomen when it was noted the "yellow anchor" had become detached. The surgeon did a visual inspection but could not find the anchor and reported he suspects it may have become caught in the adipose tissue in the abdomen. As reported, the patient has an abundant amount of adipose tissue in which the anchor and tubing was being pulled through at the time the event occurred. No additional incisions were made and the surgeon decided to close the patient and treat with antibiotics. As reported, there is no plan for additional medical or surgical intervention at this time and the anchor was left in vivo. Patient is not exhibiting any ill effects. The surgeon is not a frequent user of the echo ps device.
 
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Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7175199
MDR Text Key96752766
Report Number1213643-2018-00034
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2019
Device Catalogue Number5955460
Device Lot NumberHUBS0280
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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