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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged perforation of the ivc, filter tilt and retrieval difficulties.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model unknown g2 vena cava filter allegedly experienced difficult to remove, malposition of device and patient device interaction problem.This information was received from one source.The event involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned for evaluation, however, medical records were provided and reviewed.Therefore, the investigation is confirmed for the alleged filter tilt and retrieval difficulties, however, inconclusive for the alleged perforation of the inferior vena cava.A definitive root cause for the reported event could not be determined.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf310f vena cava filter allegedly experienced difficult to remove, malposition of device and perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient is 63 years old whose weight was 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
• MDR Report Key: 10305666
• MDR Text Key: 199841044
• Report Number: 2020394-2020-04792
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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: 09/30/2021
• Patient Sequence Number: 1