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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 5955600
Device Problems Detachment of Device or Device Component (2907); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2016
Event Type  malfunction  
Manufacturer Narrative
The balloon assembly was returned for evaluation and is confirmed for a small portion of the balloon to be detached from the rest of the balloon. Inspection of both pieces confirms that the entire balloon was removed from the patient. Visually evaluation of the echo ps balloon finds that the balloon material likely experienced a shear force during removal. It appears the user inadvertently sheared off a section of the balloon material while removing the device through the trocar, resulting in the damage that presented. As reported the balloon was pulled through the trocar during removal. The instructions for use, which are supplied with the device, prescribe that the balloon be removed simultaneously with the trocar, not pulled through the trocar, stating, "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 of the mesh in one smooth motion. Continue removing echo ps" positioning system and trocar simultaneously. " based on the event as reported and the sample evaluation the surgeon did not follow the prescribed technique for the removal of the echo ps " positioning system, which may have put additional stresses on the balloon resulting in the observed damage. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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. On (b)(6) 2016 following a successful implant of a ventralight st mesh with echo, while removing the balloon through a 12mm trocar the balloon tore into two pieces. The balloon was inflated with no issued. All pieces were removed from the body. There was no injury to the patient.
 
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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 Key6100230
MDR Text Key59863553
Report Number1213643-2016-00517
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number5955600
Device Lot NumberHUAT1335
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2016
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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