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

Catalog Number RF310F

Device Problems 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 1 out of 2 malfunctions, therefore, a lot history review was performed.The devices were not returned to the manufacturer for evaluation.However, medical records were provided for both the malfunctions in which one of the medical record included images.For one malfunction, the investigation is confirmed for the alleged filter perforation and material deformation.The investigation for the remaining malfunction is currently underway.The devices are labeled for single use.

Event Description

A review of the reported information indicates that model rf310f vena cava filter allegedly experienced filter perforation and material deformation.The information was received from various source.Both the malfunctions were involved patients with no reported consequences.Two male patients ages were ranged from 47 to 53 years; however, weight for one patient was reported as (b)(6).The remaining patient weight was unknown.

Manufacturer Narrative

H10: the lot number was provided for 1 out of 2 malfunctions, therefore, a lot history review was performed.The devices were not returned to the manufacturer for evaluation.However, medical records were provided for both the malfunctions in which one of the medical record included images.For both malfunctions, the investigations are confirmed for the alleged filter perforation and material deformation.A definitive root cause for the reported event could not be determined.The devices are 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 indicates that model rf310f vena cava filter allegedly experienced filter perforation and material deformation.The information was received from various source.Both the malfunctions were involved patients with no reported consequences.Two male patients ages were ranged from 47 to 53 years; however, weight for one patient was reported as 280 pounds.The remaining patient weight was unknown.

• 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: 11701469
• MDR Text Key: 246506977
• Report Number: 2020394-2021-80366
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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: GFSA3565,UNKNOWN
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/07/2021
• Patient Sequence Number: 1