MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM; 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 02/03/2015

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 jugular introducer sheath and storage tube was returned for evaluation.The filter was not returned.The sheath was returned in two segments.The distal tip of the storage tube was broken and lodged inside the introducer sheath hub.The distal sheath segment measured approximately 40.1cm and was kinked approximately 35.7cm from the distal tip.The distal tip was slightly buckled.The facility reported that the broken storage tube and kink in the sheath occurred during packaging for return.Functional/performance evaluation: due to the manner in which the device was returned, functional testing could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: no images or photos were provided; therefore, a review could not be performed.Conclusion: based on the returned sample condition, the investigation is confirmed for a buckled sheath tip.The investigation is inconclusive for failure to advance.Per the reported event details, the ivc was torturous; therefore, patient factors likely 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, due to a tortuous ivc the filter system was unable to be advanced to the renal takeoffs.The filter system was exchanged for another filter system that was deployed successfully.There was no reported patient injury.

• Brand Name: DENALI JUGULAR SYSTEM
• 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: 5033919
• MDR Text Key: 24234083
• Report Number: 2020394-2015-01532
• 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: Physician
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: DL900J
• Device Lot Number: GFYE3746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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