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

Catalog Number DL950J

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that during a filter placement procedure through jugular vein, the filter allegedly failed to advance through the delivery sheath.It was further reported that the filter was removed and replaced with 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 system products that are cleared in the us.The pro code and 510k number for the denali filter system products is identified in common device name and pma/510k.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was returned for evaluation.One photo was provided and reviewed.The photo shows the denali filter partially outside the storage tube.One denali jugular delivery system kit was returned for evaluation.During visual evaluation, the filter was noted to be in the storage tube partially exposed.The filter hook was noted to be dislodged from the pusher catheter within the storage tube.The mandrel was used to deploy, however, it was unsuccessful.Functional testing was not performed due to the nature of the complaint.Therefore, the investigation is confirmed for the reported failure to advance as the filter was noted to be in the storage tube partially exposed from both the provided photo and visual evaluation of the returned sample.The investigation is also confirmed for the identified device dislodged as the filter hook was noted to be dislodged from the pusher catheter based on visual evaluation of the returned sample.A definitive root cause for the reported failure to advance and identified device dislodged 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.Expiry date: 02/2025.

• 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: 15842636
• MDR Text Key: 307666174
• Report Number: 2020394-2022-00913
• 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
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: GFGP1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• 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: 65 YR
• Patient Sex: Female