MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM; IVC FILTER

Device Problems Detachment Of Device Component (1104); Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2018

Event Type  Injury  

Event Description

Meridian ivc filter found to be multiply fractured.One arm was loose in ivc, barely attached to all, other stuck in filter.Removed both arms filter with forceps.

• Brand Name: MERIDIAN FILTER SYSTEM
• Type of Device: IVC FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ
• MDR Report Key: 7591200
• MDR Text Key: 110935282
• Report Number: MW5077781
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 57 YR
• Patient Weight: 159