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

Model Number DL900J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for ten of the sixteen reported malfunctions; therefore, a lot history review could be performed.The sample was not returned to the manufacturer for evaluation; however medical records has been provided and reviewed for all the malfunctions.For 15 of the 16 malfunctions, the investigation is confirmed for perforation.The remaining one malfunction is inconclusive for perforation.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(gfyc1449, gfxh2817, gfxc2658, gfxd3899, gfau0077, gfbx1614, gfxi2541, unknown).

Event Description

This report summarizes sixteen malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced perforation.This information was received from various sources.This malfunctions involved patients with no consequences.Of the sixteen reported patients, their ages ranged from 54 ¿ 86 years and 9 were female and 6 were male.Three of the patient's weights ranged from 154 - 360 pounds.The remaining patients' weights were not provided.

• Brand Name: DENALI FILTER
• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10308585
• MDR Text Key: 199886538
• Report Number: 2020394-2020-04900
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFYL3401, GFXK0021, GFYF3842
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1