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

Catalog Number RF400F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number were provided for 1 out of 3 malfunctions, therefore, a lot history review was performed.The devices were not returned to the manufacturer for evaluation; however medical records were provided and reviewed for all the three malfunctions.The investigations for the three reported malfunctions are confirmed for perforation.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

A review of the malfunction indicated that model rf400f vena cava filter allegedly experienced perforation.This information was received from various sources.The three malfunctions involved three patients with no patient consequences.Of the reported patients, two were female and one patient was male.The age of the three reported patients ranged from 30-66 years old and the patients' weight were not provided.

• Brand Name: G2 EXPRESS FILTER SYSTEM - FEMORAL
• 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: 12203609
• MDR Text Key: 262684942
• Report Number: 2020394-2021-80670
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF400F
• Device Lot Number: GFSI2307, UNKNOWN
• Date Manufacturer Received: 06/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1