MAUDE Adverse Event Report: BARD BARD G2; FILTER

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Embolism (1829)

Event Date 02/09/2017

Event Type  Injury  

Event Description

G2 ivc filter found to be fractured with one arm embolized to left lung and other caught locally in filter in ivc, still loose.All pieces removed.

• Brand Name: BARD G2
• Type of Device: FILTER
• Manufacturer (Section D): BARD; tempe
• MDR Report Key: 6325826
• MDR Text Key: 67370083
• Report Number: MW5067845
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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): Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 86