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

Model Number	2120F
Medical Device Problem Code	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 indicates that model 2120f vena cava filter allegedly perforated.The information was received from a single source.One patient was involved with no reported patient injury.The female patient is (b)(6) and weighs (b)(6) pounds.
Additional Manufacturer Narrative
The lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).Based on the available information, the definitive root cause is unknown.The device is labeled for single use.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13288406
• Report Number: 2020394-2022-90042
• Device Sequence Number: 17244632
• 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: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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 Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 01/19/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown