MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER; VENA CAVA FILTER

Catalog Number RF400F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number for the two devices was not provided, a lot history review was not performed.The samples were not returned to the manufacturer for evaluation; however, medical records were received for one malfunction and reviewed.The investigation of the reported malfunction is confirmed for filter migration, tilt, detachment and perforation.For the other malfunction, the investigation is inconclusive as no objective evidence was provided for review.Based upon the available information, the definitive root cause for these malfunctions is unknown.The devices were labeled for single use.(b)(4).

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that the model rf400f vena cava filter allegedly reported migration, tilt, detachment and perforation.This information was received from various sources.The two malfunctions involved patients with no known impact to the patient.The first patient's age, sex and weight was unknown; however, the second patient was (b)(6) male and the weight was unknown.

Manufacturer Narrative

H10: the lot number for the two devices were not provided, so lot history reviews were not performed.The samples were not returned to the manufacturer for evaluation; however, medical records were received for both malfunctions and reviewed.One malfunction include images within the medical records.For both malfunctions, the investigation is confirmed for filter tilt, migration, filter limb detachment and perforation of the inferior vena cava.Based upon the available information, the definitive root cause for these malfunctions is unknown.The devices were 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 two malfunctions.A review of the reported information indicated that the model rf400f vena cava filter allegedly experienced migration, tilt, detachment and perforation.This information was received from various sources.The two malfunctions involved patients with no known impact to the patient.The two male patients ages were reported ranging from 46 to 58 years and weight was not provided for both patients.

• Brand Name: G2X FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10308238
• MDR Text Key: 199880666
• Report Number: 2020394-2020-04890
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: UNKNOWN
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1