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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Manufacturer Narrative

For both malfunctions, the lot numbers were not provided and lot history reviews were not performed.The devices were not returned to the manufacturer for evaluation; however, medical records were provided for both malfunctions and medical records included images.For both malfunctions, the investigation is confirmed for perforation of inferior vena cava, filter tilt and material deformation.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 malposition of device, patient device interaction problem and material deformation.This information was received from various sources.This malfunction involved two patients with no consequences.Two female patients age were reported ranging from 54 to 66 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: 12200350
• MDR Text Key: 262869808
• Report Number: 2020394-2021-80657
• 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

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