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

Catalog Number DL950J

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl950j vena cava filter allegedly experienced difficulty to remove.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not reported.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The device and an xray were provided and the evaluation identified damage to the sheath.No filter was found in the provided xray.The definitive root cause could not be established.The device is labeled for single use.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 dl950j vena cava filter allegedly experienced difficulty to remove.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not reported.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation and identified introducer sheath damage.The definitive root cause could not be established.The device is labeled for single use.H10: g4 h11: b5, 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl950j vena cava filter allegedly experienced difficulty to remove and deformation due to compressive stress.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not reported.

• Brand Name: DENALI FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8813313
• MDR Text Key: 151790156
• Report Number: 2020394-2019-01703
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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: 01/17/2020

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 Catalogue Number: DL950J
• Device Lot Number: GFBX4190
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 12/31/2019
• Supplement Dates FDA Received: 10/11/2019; 01/17/2020
• Patient Sequence Number: 1