• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. DENALI FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8813313
MDR Text Key151790156
Report Number2020394-2019-01703
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040818
UDI-Public(01)00801741040818
Combination Product (y/n)N
Number of Events Reported1
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 NumberDL950J
Device Lot NumberGFBX4190
Initial Date Manufacturer Received 06/30/2019
Initial Date FDA Received07/22/2019
Supplement Dates Manufacturer Received09/30/2019
12/31/2019
Supplement Dates FDA Received10/11/2019
01/17/2020
Patient Sequence Number1
-
-