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

Model Number DL900J

Device Problems Positioning Failure (1158); Device Contamination with Chemical or Other Material (2944); Activation Failure (3270)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).

Event Description

It was reported during a filter placement procedure, the device allegedly failed to deploy.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 was returned for evaluation.Filter appeared to be bloody, received in deployed position and all legs are present and uncrossed.Therefore, the investigation is inconclusive for failure to expand, as the returned filter legs were uncrossed and there is no proper evidence.A definitive root cause for the alleged failure to expand could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 10/2023).H11: section a through f ¿ the information provide by bd represents all 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 filter placement procedure, the device allegedly failed to deploy.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
• MDR Report Key: 11326635
• MDR Text Key: 231935465
• Report Number: 2020394-2021-00247
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFEW3175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other