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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was not returned for evaluation.Medical records were provided and reviewed.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

A review of the reported information indicated that model rf310f vena cava filter experienced material deformation, perforation and tilt.The information was received from a one source.This malfunction involved one patient with no patient consequences.The male patient is (b)(6) years old.Weight of the patient was not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation.Medical records were provided and reviewed.Therefore, the investigation is confirmed for the perforation, tilt and material deformation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g3, h6(method) h11: h6(result, conclusion) 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

A review of the reported information indicated that model rf310f vena cava filter experienced material deformation, perforation and tilt.The information was received from a one source.This malfunction involved one patient with no patient consequences.The male patient is 67 years old.Weight of the patient 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: 11697783
• MDR Text Key: 247466104
• Report Number: 2020394-2021-80346
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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: GFRH5514
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/02/2021
• Patient Sequence Number: 1