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

Model Number	2120F
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A review of the reported information indicated that model 2120f vena cava filter allegedly experienced malposition of device and patient-device incompatibility.This information was received from various sources.Of the two malposition of device and patient-device incompatibility, both involved patients without consequences.The two female patients ranged from 51 to 62 years of age and one patient weighed (b)(6) lbs.Weight was not reported for the other patient.

• Brand Name: SIMON NITINOL FILTER SYSTEM- FEMORAL
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12708231
• Report Number: 2020394-2021-80793
• Device Sequence Number: 4614078
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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
• Operator of Device: No Information
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFVJ3955, UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/27/2021
• Patient Sequence Number: 1