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

Catalog Number DL950J

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

No device or no medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The investigation of the reported event is currently underway.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 jugular deployment of a vena cava filter, the guidewire was allegedly difficult to pass through the distal end of the dilator which appeared to be flattened.It was further reported that during deployment of the filter in the ivc, two of the filter arms allegedly did not open properly.The health care provider decided to leave the filter at the deployed location as there were no other complications and the filter was scheduled for removal in less than four weeks.There was no reported patient injury.

Manufacturer Narrative

The device history records were 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 & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image review: based on the image provided, due to image quality the identity the filter cannot be confirmed.Based on the image provided, a significant narrowing of the ivc was demonstrated at the location of the filter deployment, can be confirmed.Based on the image provided, the filter appears to have fully expanded against the confines of the ivc wall, can be confirmed.Based on the image provided, two filter arms that reportedly did not fully expand cannot be confirmed.Additional images of the filter deployment would be needed to confirm if two filter arms did not fully expand.As noted significant narrowing of the ivc was demonstrated at the location of the filter deployment, the filter appears to have fully expanded against the confines of the ivc wall.Photo review: two digital photos were reviewed.The first photo show the label of the device in question identify the catalog number as dl950j and lot number gfav2093.The second digital photo shows one dilator with the tip deformed.The investigation can be confirmed for the dilator tip deformation.Conclusion: the device was not returned.Images were provided.Photos were provided.Based on the photos, the investigation can be confirmed for the deformed dilator tip.Based on the images, the investigation was inconclusive for the failure to expand legs of the filter.Due to the limited image quality and amount of images returned, it cannot be confirmed if the legs of the filter did not fully expand at deployment.It can be confirmed at the time images were taken that it appears the filter is fully expanded within the narrowed ivc.Based upon the available information, the definitive root cause was unknown.Labeling review: the current ifu (instructions for use) states: warnings: - delivery of the denali filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.Precautions: - do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, un-sheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher at anytime during this procedure.Potential complications: - failure of filter expansion/incomplete expansion.(conclusion code); 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 jugular deployment of a vena cava filter, the guidewire was allegedly difficult to pass through the distal end of the dilator which appeared to be flattened.It was further reported that during deployment of the filter in the ivc, two of the filter arms allegedly did not open properly.The health care provider decided to leave the filter at the deployed location as there were no other complications and the filter was scheduled for removal in less than four weeks.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 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6138993
• MDR Text Key: 61245587
• Report Number: 2020394-2016-01128
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: DL950J
• Device Lot Number: GFAV2093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 50