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

Catalog Number DL950J

Device Problems Positioning Failure (1158); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified in.Expiration date: 05/2024.

Event Description

It was reported that during a vena cava filter placement procedure via a lesion through the neck to treat acute venous thrombus, the filter allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one jugular denali filter kit was returned for evaluation.While receiving the pusher catheter loaded onto the touhy-borst adapter and connected to the storage tube.Based, on the image review and returned sample analysis the investigation is confirmed for failure to expand the filter.However, the investigation is inconclusive for failure to deploy as the identified failure to expand issue might led to the deployment issue.One fluoroscopic video was reviewed.The video shows an inferior vena cava filter was being deployed likely from neck access.The filter appears to not fully deploy when released from its sheath.Specifically, filter legs are possibly entangled.Based on the image review the failure to expand issue can be confirmed.A definitive root cause for the alleged failure to deploy and identified failure to expand issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified in d2 and g4.H10: d4 (expiration date: 05/2024).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during a venacava filter placement procedure via a lesion through the neck to treat acute venous thrombosis, the filter allegedly failed to deploy.The procedure was completed using another device.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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13073459
• MDR Text Key: 282782330
• Report Number: 2020394-2021-02105
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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 Catalogue Number: DL950J
• Device Lot Number: GFFS0353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/30/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 29 YR
• Patient Sex: Female