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

Model Number DL900J

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, a lot number was provided, and lot history review was performed.The device was not returned to bd for evaluation, but an image was provided for review.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced a deployment issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient was a (b)(6) year old female; weight was not provided.

Manufacturer Narrative

H10: for the reported malfunction, a lot number was provided, and lot history review was performed.The device was not returned to bd for evaluation, but an image was provided for review.The images review identified partial deployment.The root cause could not be determined.The device is labeled for single use.H11: h6 (results, 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 one malfunction.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced a deployment issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient was a 81 year old female; weight was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced a deployment issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient was a 81 year old female; weight was not provided.

Manufacturer Narrative

H10: the lot number was provided, therefore a lot history review was not performed.The sample was not returned and the investigation is confirmed for partial deployment and failure to expand through image and photo review.The definitive root cause could not be determined based upon available information.The device was labeled for single use.H10: g4.H11: g1, h6 (device code).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.

• Brand Name: DENALI FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9590852
• MDR Text Key: 179310172
• Report Number: 2020394-2020-00267
• 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,Followup
• Report Date: 07/10/2020

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: GFDX0637
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 06/30/2020
• Supplement Dates FDA Received: 04/02/2020; 07/10/2020
• Patient Sequence Number: 1