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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 5955450
Device Problem Use of Device Problem (1670)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 02/09/2018
Event Type  Injury  
Manufacturer Narrative
Based on the events as reported, the echo ps positioning system was not removed from the patient as prescribed in the instructions for use (ifu). This complaint is confirmed as use related with no malfunction of the device. An in-service training has been scheduled and will include the new or staff at the facility. The warning section of the instructions-for-use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant. " the instructions-for-use also prescribes the proper method for use. 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
As reported the patient underwent robotic repair of an incisional hernia using a ventralight st w/ echo ps. As reported the case went well and the patient was brought to the pacu. The surgeon was performing another surgical case with the same device and as he was removing the ps balloon, he questioned his assistant who was with him in the previous case, if she removed the positioning balloon as he had instructed her to do. The assistant was unsure and the surgeon then ordered a ct scan to attempt visualization of the device. As the device is not radiopaque it was not seen per ct scan and the surgeon decided the patient had to go back under anesthesia and additional surgery to find and remove the portion of the device left in vivo. Once the patient was opened up, the positioning system was visualized and removed in full. The patient was sent back to recovery with no further reported complication. The surgeon is reported to be a long-time experienced user of the echo ps device. The or assistant is reported to have only been in the or for 3 weeks and is not an experienced 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 Key7317040
MDR Text Key101616170
Report Number1213643-2018-00466
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5955450
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 Received02/09/2018
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 Treatment Data
Date Received: 03/06/2018 Patient Sequence Number: 1
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