MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) DENALI FILTER; VENA CAVA FILTER

Model Number DL900J

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported three malfunctions were not provided, therefore a lot history review could not be performed.All three malfunctions devices were not returned for evaluation, however medical record were provided for review.Two of three malfunctions were confirmed for filter tilt and perforation of the inferior vena cava filter.The definite root cause could not be determined based on the available information.The company is still investigating the issue at this time for one malfunction.The device is labeled for single use.

Event Description

This report summarizes three malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced malposition of device and patient device interaction problem.The information was received from various sources.All three malfunctions involved patients with no reported patient injury.The three patients ranged from 47-77 years of age and weight is not provided.Of the reported patients, two were male and one gender was not provided.

Manufacturer Narrative

H10: the lot numbers for the reported three malfunctions were not provided, therefore a lot history review could not be performed.All three malfunctions did not return devices, however medical records were provided for review.The three malfunctions were confirmed for filter tilt and perforation of the inferior vena cava filter.The definite root cause could not be determined based on the available information.The device is labeled for single use.H11: h6 (result, conclusion).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.

Event Description

This report summarizes three malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced malposition of device and patient device interaction problem.The information was received from various sources.All three malfunctions involved patients with no reported patient injury.The three patients ranged from 47-77 years of age and weight is not provided.Of the reported patients, two were male and one gender was not provided.

• Brand Name: DENALI FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 10314041
• MDR Text Key: 200054346
• Report Number: 2020394-2020-05000
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1