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

Catalog Number DL900J

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2013

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.This is the only event reported to date for this lot number and failure mode.Visual inspection: returned for evaluation is the denali jugular filter delivery system; the sheath was not returned.The dilator was returned; the distal tip was buckled/flared.The delivery pusher catheter was kinked; however, the manner in which the device was packaged for return may have contributed to the kink since no catheter kinks were reported by the user.The tuohy-borst was returned loose.The storage tube was visually examined and no anomalies were identified.The returned filter exhibited all 6 arms and 6 legs which were present and intact.No other anomalies were identified on the returned device.Dimensional evaluation was performed on the filter and all measurements met the required specifications.Functional/performance evaluation: the delivery sheath was not returned for evaluation and the cause for the filter becoming stuck inside the delivery sheath could not be determined.Medical records review/image/photo review: medical records were not provided.No images or photos were provided.Conclusion: based upon the condition of the returned device (i.E.No sheath and a deployed filter), the complaint investigation is inconclusive for the filter failing to advance through the sheath.The investigation is confirmed for a buckled dilator tip.It is possible the user inserted the dilator into the sheath at an angle causing the dilator tip to buckled.However, the definitive root cause is unknown.Based upon the available information, the definitive root cause for the advancement issues is unknown.It is unknown if procedural factors contributed to the reported event.Labeling review: the denali vena cava filter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 during a vena cava filter deployment procedure, the filter became stuck inside the delivery sheath and could not be deployed; therefore, the filter and delivery system were exchanged for a new vena cava filter that was prepped and deployed successfully.There is no reported patient injury.

• Brand Name: DENALI FILTER
• 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: 5026028
• MDR Text Key: 23941219
• Report Number: 2020394-2015-01358
• 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
• Reporter Occupation: Health Professional
• Report Date: 09/06/2013

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: 07/31/2015
• Device Catalogue Number: DL900J
• Device Lot Number: GFXF3380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2013
• 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