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

Catalog Number DL950J

Device Problem Activation Failure (3270)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to expand.The device was removed and the procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in device information 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 common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, images and videos were provided for review.The investigation of the reported event is currently underway.Expiration date: 02/2025.

Manufacturer Narrative

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: 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 delivery system kit was returned for evaluation.The filter was received in a deployed position.There is no anomaly noted to the device.Therefore, based on the sample evaluation, the investigation is inconclusive for the reported failure to expand issue.Eleven fluoroscopic images were reviewed.The images demonstrate a vena cava filter in place.The filter legs, however, are not appropriately expanded.It is challenging to assess the fine details due to image clarity, but it appears that some of the filter legs may be entangled with each other prohibiting expansion against the vena cava wall.At one point in the procedure, the physician has successfully expanded a few of the filter legs, although the rest remain confined.From the sequence of images provided it appears that the filter has been removed successfully.Therefore, based on the image review the investigation is confirmed for the failure to expand issue.Three fluoroscopic videos were reviewed.The video show a vena cava filter in place but the legs to not appear appropriately expanded.There is a catheter presumably traveling down from right neck venous access that appears to attempt to untangle and expand the filter legs, albeit unsuccessfully.Therefore, the investigation is confirmed for the reported failure to expand issue as the filter is failed to expand.A definitive root cause for the reported 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: d4 (expiration date: 02/2025),.

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to expand.The device was removed and 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15866808
• MDR Text Key: 307669026
• Report Number: 2020394-2022-00941
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2022
• 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: GFGP0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG