MAUDE Adverse Event Report: BARD BARD G2 IVC FILTER

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Foreign Body In Patient (2687)

Event Date 05/08/2017

Event Type  Injury  

Event Description

The pt had a bard g2 ivc filter placed in 2007.He presented for filter removal in 2017 and it was determined the filter was fractured, tip embedded and had a penetrated leg before removal attempt was made.The filter and the fractured component were removed on (b)(6) 2017.

• Brand Name: BARD G2 IVC FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): BARD
• MDR Report Key: 6562819
• MDR Text Key: 75169977
• Report Number: MW5069722
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR