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

Catalog Number 5955790

Device Problems Break (1069); Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

At this time a root cause determination cannot be made.Based on the information provided to date, it is unclear what section of the positioning system broke and when in the process of use this occurred.There are multiple parts to the positioning system and specific details have not been provided.Davol has reached out the surgeon; however at this time additional information has not been provided.To date this is the only reported complaint for this production lot of (b)(4) units, released for distribution in june, 2017.A review of the manufacturing records was performed and no issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing procedures, inspection procedures, as documented in the work order.Product passed all required inspections.There were no manufacturing abnormalities that may have contributed to this complaint.Should additional information be provided and if the device is returned for evaluation, a supplemental emdr will be submitted.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

It was reported that during a laparoscopic ventral hernia procedure while using a davol ventralight st with echo ps, the positioning system was broken into two pieces.As reported the echo ps was removed from the body and the case was completed.There was no patient injury.

Manufacturer Narrative

This is an addendum to the initial emdr to document the receipt and evaluation of the sample.The echo ps balloon assembly was returned sheared in two pieces.In another area a tear was found in the balloon material, with no detachment of material.All portions were returned in full, no pieces missing.No manufacturing anomalies were found.The echo ps experienced trauma that resulted in separation of the material during removal.While we did ask additional questions the user has not chosen to respond to our request for information.Based on the condition of the device the user appears to have attempted to removed the echo ps balloon by pulling it out through the trocar.Pulling it our through the trocar can result in the type of damage that was identified with the returned sample.The echo ps, the instructions-for-use states, "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." root cause is identified at this time to be use related.

• 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: 7307080
• MDR Text Key: 101525709
• Report Number: 1213643-2018-00432
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762
• Combination Product (y/n): N
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: 5955790
• Device Lot Number: HUBS1131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2017
• 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