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 06/28/2021

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 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 in section 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 510 k number for the denali filter system products are identified.(expiry date: 02/2024).

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to expand and the limbs were noted to be twisted.If was further reported that a snare was used to spread the twisted limb through a femoral approach.There was no reported patient injury.

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to expand and the limbs were noted to be twisted.It was further reported that a snare was used to spread the twisted limb through a femoral approach.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 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 510 k number for the denali filter system products 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: the physical device was not returned for evaluation.One fluoroscopic video was reviewed.The video demonstrates a filter placement likely from the neck.Before the filter catheter is fully removed, it appears that at least two of the filter legs are twisted in an abnormal position.A snare device is visualized traveling from the right groin.The video shows the snare being manipulated to capture one of the legs of the filter so that the filter can be deployed while simultaneously straightening the filter legs during deployment.At finally, the device at a satisfactory anatomic location and virtually fully expanded, although at least one of the filter legs remains slightly rotated or twisted.Based on the image review, the investigation is confirmed for reported failure to expand.A definitive root cause for the alleged failure to expand 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.The instructions for use states: warnings:- delivery of the denali® filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.H10: d4 (expiry date: 02/2024).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.H3 other text : device not returned.

• 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: 12208120
• MDR Text Key: 262861283
• Report Number: 2020394-2021-01368
• Device Sequence Number: 1
• Product Code: DTK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• 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: GFFP0541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other