MAUDE Adverse Event Report: BARD BARD G2 IVF FILTER; G2 FILTER

Device Problems Fracture (1260); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/02/2016

Event Type  Injury  

Event Description

G2 ivc filter found to be fractured at time of removal, filter and fragment removed with forceps.Filter had 3 prior failed attempts to removal due to tip embedding.It is possible these events may have affected filter integrity.

• Brand Name: BARD G2 IVF FILTER
• Type of Device: G2 FILTER
• Manufacturer (Section D): BARD
• MDR Report Key: 5702686
• MDR Text Key: 46765417
• Report Number: MW5062670
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 68