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

Catalog Number 5955450

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As reported the user did not cut the inflation tube prior to pulling it through the abdomen during removal of the inflation assembly.By not cutting the inflation tube the yellow anchor would be left on the inflation tube during removal, and would most likely get caught behind the mesh or possibly on the trocar during removal.Based on the event as reported, the sample evaluation and the investigation activities performed the anchor detached from forces applied during the removal process as the surgeon would have had to apply excess force to remove the inflation tube with the yellow anchor still present.The instructions-for-use instruct the user to cut the inflation tube as close to the skin as possible prior to removal.Had the user done this the yellow anchor portion of the inflation tube would have been removed prior to pulling it through the abdomen.The sample evaluation confirms detachment of the yellow anchor form the inflation tube.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No manufacturing issues associated to the reported event were found in the reviewed lot.

Event Description

It was reported that on (b)(6) 2019 a bard/davol ventralight st w/ echo ps was used during a laparoscopic hernia repair procedure.As report the surgeon placed and fixed the mesh in place with no issues reported.However, when the surgeon was removing the echo ps inflation assembly, it was noted that the yellow anchor had become detached from the device.The yellow anchor was located easily and removed without an additional medical intervention.As reported, the surgeon is an experienced user of the device.No patient injury.

• 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: 8728802
• MDR Text Key: 149059737
• Report Number: 1213643-2019-05379
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5955450
• Device Lot Number: HUDN1489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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 Age: 70 YR