MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, lot number was not provided and a lot history review could not be performed.The sample was not returned for evaluation and medical records were provided.Filter limb perforation, detachment and material deformation was confirmed.However, the investigation unconfirmed for filter tilt.A root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf310f.Vena cava filter allegedly experienced detachment of device or device component, material deformation and patient device interaction problem.This report was received from a single source.This malfunction did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is female, and the weight is (b)(6) lbs.

• Brand Name: G2 FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9597668
• MDR Text Key: 178330101
• Report Number: 2020394-2020-00534
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1