MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR DENALI VENA CAVA FILTER

Catalog Number DL900J

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 07/06/2016

Event Type  malfunction  

Event Description

The tip of the introducer sheath came off during a jugular vein approach for insertion of a vena cava filter.Difficulty was encountered when attempting to deploy the vena cava filter as it deployed too early and was malpositioned.A second vena cava filter was placed below the first one.

• Brand Name: DENALI VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 5815054
• MDR Text Key: 50327649
• Report Number: MW5063579
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: DL900J
• Device Lot Number: GFYL3330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 61