MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. G2 IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Fracture (1260); Material Fragmentation (1261); Migration (4003)

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

Event Date 10/03/2018

Event Type  Injury  

Event Description

G2 ivc filter found to be fractured with one arm embolized to the left pulmonary artery.Filter removed with forceps (top embedded) and fragment removed from pulmonary artery.

• Brand Name: G2 IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC. ; tempe AZ
• MDR Report Key: 7938401
• MDR Text Key: 123107705
• Report Number: MW5080364
• Device Sequence Number: 0
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• 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: 26 YR
• Patient Weight: 62