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

Catalog Number RF310F

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Of the two devices, one lot number was provided and a lot history review was performed.The devices were not returned to the manufacturer for evaluation; however, medical records were provided for both malfunctions.For both malfunctions, the investigation is confirmed for filter limb detachment.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

A review of the reported information indicated that model rf310f vena cava filter allegedly experienced detachment of device or device component.This information was received from various sources.This malfunction involved two patients with no consequences.One female and one male patients age were reported ranging from 36 to 69 years.All other details of the patients were not provided.

• Brand Name: G2 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: 12199451
• MDR Text Key: 262645359
• Report Number: 2020394-2021-80631
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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: GFPI3171, UNKNOWN
• Date Manufacturer Received: 06/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1