MAUDE Adverse Event Report: C. R. BARD, INC. DENALI VENA CAVA FILTER FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number REF DL900F

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/25/2018

Event Type  Injury  

Event Description

Deployed ivc filter and it did not open.Able to deploy second filter with different lot number correctly.Misplaced ivc filter considered to be of no risk for causing problems or disability for pt, and she is protected with the ivc filter that is in proper location of the vena cava.

• Brand Name: DENALI VENA CAVA FILTER FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7842313
• MDR Text Key: 119262519
• Report Number: MW5079538
• 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: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: REF DL900F
• Device Lot Number: GFCT2167
• Was Device Available for Evaluation?: No
• 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: 73 YR
• Patient Weight: 104