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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 5955113
Device Problems Material Separation (1562); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
This complaint is inconclusive for the as reported condition (would not hold air) as the condition of the returned sample did not allow for identification of the reported condition. The balloon material was noted to be torn in two locations. The inflation tube was detached from the balloon assembly and not returned with the sample. The evaluation of the torn balloon material notes the material to be frayed, confirming that the material was sheared and not intentionally cut, as there would be no frayed material had the balloon been cut. The condition is consistent with what can present if the balloon assembly is pulled through the trocar to remove from the body. User confirmed to have removed the balloon from the trocar. Based on the sample evaluation and the event as reported the user removed the echo ps balloon by pulling it through the trocar not simultaneously with the trocar as prescribed in the ifu. The ifu 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. Begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard® logo. Begin pulling the positioning system off the mesh in one smooth motion. Continue removing the echo ps¿ positioning system, pulling it up to the tip of the trocar. Remove both the echo ps¿ positioning system and trocar simultaneously. Verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully, discard the echo ps¿ positioning system appropriately. A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution on 06/30/2016. Root cause of the torn material is use of device issue. 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.
 
Event Description
It was reported that on (b)(6) 2017 a bard ventralight st w/ echo ps was being used during a laparoscopic ipom procedure. As reported the echo ps (balloon) would not hold air during inflation. The mesh was successfully implanted without the use of the echo ps. Following implantation and fixation the echo ps was removed through a 12 mm trocar. The entire echo ps was removed from the patient, the mesh remains implanted. As reported the location of the leakage could not be identified. The hcp is reported to be an experienced user of the device and there was no injury to the patient. The sample was returned with the balloon torn in two locations and damage is consistent with what can present if the balloon assembly is removal through the trocar. All pieces were accounted for in this case. If this were to recur it is possible that a fragment could detach and go undetected or be left in the body. As such a malfunction mdr is being reported.
 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6694938
MDR Text Key79520383
Report Number1213643-2017-00390
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Catalogue Number5955113
Device Lot NumberHUAS1069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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