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

Lot Number GFZJ0207

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2016

Event Type  malfunction  

Event Description

An (b)(6) female with history of dvt had a bard ivc filter placed on (b)(6) 2016 at (b)(6).On (b)(6) 2016, on removal of the filter at (b)(6) hospital one of the metal legs of the filter fractured and broke off and had to be retrieved.

• Brand Name: BARD PERIPHERAL VASCULAR
• Type of Device: DENALI VENA CAVA FILTER
• Manufacturer (Section D): BARD; salt lake city UT
• MDR Report Key: 6226577
• MDR Text Key: 64205000
• Report Number: 6226577
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Lot Number: GFZJ0207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2016
• Distributor Facility Aware Date: 12/15/2016
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2016
• 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 Age: 81 YR