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

Catalog Number DL900J

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records have been made available to the manufacturer.One photo and two x-ray images of the filter have been provided.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.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 approximately nine months post deployment of a vena cava filter, during a scheduled retrieval, upon removal of the filter from the patient, the filter legs were allegedly bound by what appeared to be a rigid piece of black plastic.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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/photo review: based on the images provided, a bard denali filter was deployed in an upright position in the ivc, can be confirmed.Based on the images provided, the filter limbs were fully expanded against the confines of the vena cava wall; post filter deployment and prior to filter retrieval, can be confirmed.Based on the images provided, a black band was demonstrated around the filter legs causing them to be bound together; post filter retrieval, can be confirmed.Conclusion: the device was not returned.Medical records were not provided.Images were provided and reviewed.Based on the provided images, the investigation can be confirmed for foreign material.The material was not present on the filter before retrieval, it had to be introduced by the retrieval device.Per the provided images, there was no foreign material present on the legs of the filter prior to deployment.The foreign material was only observed once the filter was removed from the patient.Therefore, the foreign material had to be introduced from the retrieval device.However, the definite root cause was unknown.Labeling review: the current ifu (instructions for use) states: warnings: remove the denali® filter using an intravascular snare only.Precautions: the retrieval of the denali® vena cava filter should only be performed using minimum 9f i.D./11f i.D.Dual retrieval sheaths.Misuse of these devices or improper retrieval technique may result in intimal injury or caval narrowing.Care should be taken when advancing the 9f retrieval sheath in the caudal direction to avoid completely covering the arms and legs.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 approximately nine months post deployment of a vena cava filter, during a scheduled retrieval, upon removal of the filter from the patient, the filter legs were allegedly bound by what appeared to be a rigid piece of black plastic.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: 6233305
• MDR Text Key: 64176785
• Report Number: 2020394-2016-01240
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)170531(10)GFYD2732
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: DL900J
• Device Lot Number: GFYD2732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• 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