MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number 0115311

Device Problems Material Frayed (1262); Difficult To Position (1467); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device in question is being returned to davol for evaluation.The sample has not been received at this time.If / when the sample is returned and an evaluation has been completed a supplemental mdr will be submitted to document the results.Currently it is unknown why the user had difficulty in placing the device.If a malfunction of this nature were to recur it is not expected that a user would choose to prolong the case for such an extended period of time (1-2 hours) before attempting to use an alternative device.The recurrence of the reported malfunction/condition may in some cases prevent the device from being used, however the process of switching to alternative device if needed is anticipated to result in only an inconsequential delay, while the device is being exchanged for another.As was identified in the reported complaint the switch out to the alternative device took approximately 3 minutes.The likelihood that another user would prolong the case for such a long period as was reported is considered to be remote.Therefore it is not anticipated that the recurrence of a malfunction of this nature is likely to cause or contribute to death or serious injury upon recurrence.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.The patient information could not be obtained due to the personal information protection law in (b)(6).

Event Description

It was reported that during a laparoscopic hernia repair procedure, the bard 3dmax mesh could "not be used smoothly." as reported the user attempted to place the mesh in the correct anatomical location to facilitate repair for an extended period of time (1-2 hours).After being unsuccessful in placing the device the surgeon removed the mesh from the site and used another 3dmax mesh that was on hand and completed the procedure in 3 minutes time.The mesh had not been fixated and there was with no change in surgical approach and remained a laparoscopic procedure.The event did not result in patient injury, or necessitate surgical intervention as the mesh was removed from the site without issue and another placed.As reported the extension of surgery time did not result in any adverse patient outcome.The surgeon is reported to be an experienced user of the product having used it for more than 3-years.As reported, there was nothing abnormal about the patient anatomy that contributed to the difficulty.

Manufacturer Narrative

This is an addendum to the initial mdr to document the results of the manufacturing review and sample evaluation.A review of the manufacturing records was performed and found that the lot was manufactured to specification.A review of the ifu instructs the user to use an appropriate sized trocar to allow the mesh to slide down the trocar with minimal force.In the event the mesh will not easily deploy down the trocar, remove trocar and insert mesh through incision.An 11mm internal diameter trocar is recommended for a large 3dmax mesh.The sample evaluation finds for fraying of the edge seal and tearing of the mesh.As reported the user prolonged the case for an extended period of time (1-2 hours) before choosing to use an alternative device.The damage observed is consistent with user/device interface for an extended period of time during the prolongation of the case.The sample evaluation did not identify the condition of the mesh as an out of box condition.The reason for the user experiencing difficulty in placing the device initially, is unknown.

• Brand Name: 3DMAX
• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6544846
• MDR Text Key: 74639815
• Report Number: 1213643-2017-00282
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)210728(10)HUAV0081
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081010
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 0115311
• Device Lot Number: HUAV0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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