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

Catalog Number DL950F

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images and videos were provided for review.The investigation of the reported event is currently underway.(expiration date: 10/2024).

Event Description

It was reported that during a filter placement procedure via the right femoral vein, the propulsive liner and propulsive guide wire allegedly detached.It was further reported that propeller allegedly migrated to the heart.Reportedly the patient allegedly experienced transient cardiac pain.The current status of the patient is unknown.

Event Description

It was reported that during a filter placement procedure via the right femoral vein, the propulsive liner and propulsive guide wire allegedly detached.It was further reported that propeller allegedly migrated to the heart.Reportedly the patient allegedly experienced transient cardiac pain.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is 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.Three images and two videos were provided and reviewed.The fluoroscopic images shows a propulsion system which is detached from the delivery system.The image also shows a guide catheter and a snare used to retrieve the propulsive tip.One of the images depicts the cardiac monitor with apparent irregularity.The fluoroscopic video shows the propulsive tip floating in the right atrium.Therefore, based on the image and video review, the investigation is confirmed for the reported detachment issue.A definitive root cause for the reported detachment 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: 10/2024), g3, h6 (method).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.

• Brand Name: DENALI FEMORAL 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: 16031292
• MDR Text Key: 305974584
• Report Number: 2020394-2022-01000
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL950F
• Device Lot Number: GFFX2209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male