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

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The sample was not returned for evaluation, however medical records were provided for review.The investigation is confirmed for malposition of the device, patient device interaction problem, detachment, material deformation, and inconclusive for migration.The root cause could not be determined.The device is labeled for single use.(device code: (b)(4)).

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model rf310f, vena cava filter, allegedly experienced migration of device or device component, malposition of device, detachment of device or device component, material deformation, and patient device interaction problem.This information was received from a single source.This malfunction involved a (b)(6) year old female patient with no consequences.The patient's weight was not provided.

• 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: 9596387
• MDR Text Key: 178182865
• Report Number: 2020394-2020-00453
• 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: GFSJ2332
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1