MAUDE Adverse Event Report: BARD BARD DENALI VENA CAVA FILTER; FILTER INTRAVASCULAR

Catalog Number DL900J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2017

Event Type  Injury  

Event Description

Ivc filter incorrectly deployed within the sheath.Sheath taken out.No adverse reaction noted.

• Brand Name: BARD DENALI VENA CAVA FILTER
• Type of Device: FILTER INTRAVASCULAR
• Manufacturer (Section D): BARD
• MDR Report Key: 6975834
• MDR Text Key: 90334381
• Report Number: MW5072941
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: DL900J
• Device Lot Number: GFBU1468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR