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

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.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7317040
• MDR Text Key: 101616170
• Report Number: 1213643-2018-00466
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5955450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention