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

Catalog Number RF400F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; however, medical records were received and reviewed.The investigation is confirmed for filter tilt.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf400f vena cava filter allegedly experienced malposition (tilt) of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6) year old male whose weight was not reported.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; however, medical records were received and reviewed.The investigation is confirmed for filter detachment, perforation of the inferior vena cava (ivc), filter tilt and material deformation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4, h6 (device: 4001, 2616).H11: b5, g1.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 rf400f vena cava filter allegedly experienced malposition (tilt) of device, positioning problem, filter detachment, perforation beyond the ivc wall, material deformation.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 69-year-old male whose weight was not reported.

• Brand Name: G2 X 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: 8819780
• MDR Text Key: 152051637
• Report Number: 2020394-2019-01776
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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: GFSC1017
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1