MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FILTER FEMORAL; VENA CAVA FILTER

Catalog Number DL900F

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2014

Event Type  malfunction  

Manufacturer Narrative

A further review of this event was performed and identified a change in the mdr reportability pursuant to 21 cfr part 803.Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: one denali femoral filter delivery system with a deployed filter was returned for evaluation.No anomalies were identified on the returned components.The introducer sheath was evaluated and no anomalies were identified inside the lumen as well as outside.The returned filter exhibited all 6 arms and 6 legs present and intact.No foreign materials were identified on the returned device.Functional/performance evaluation: heat was applied to the returned filter and filter took the appropriate shape.Measurements were conducted and all measurements met the required specifications.Medical records review_ image/photo review: medical records were not provided.No images or photos were provided.Conclusion: the complaint investigation is inconclusive for the reported event.Based upon the available information, the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: contents are supplied sterile.Do not use if the product sterilization barrier or its packaging is compromised.Inspect the packaging to ensure that it has not been opened or damaged.Additionally, specific warnings, precautions, and potential complications associated with the device are included in the ifu.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.

Event Description

It was reported that while advancing the vena cava filter through the deployment sheath an object appeared to be in front of the filter; therefore, the vena cava filter system was exchanged for a new filter that was deployed successfully.After completion of the procedure, the system was examined and no foreign object or material was found in the deployment system or on the filter.There was no reported patient injury.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the user facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility did not have any additional details to provide at this time.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.

• Brand Name: DENALI FILTER FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5037183
• MDR Text Key: 24360068
• Report Number: 2020394-2015-01538
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: DL900F
• Device Lot Number: GFXI2527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• 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