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
Additional 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 and reviewed for both the malfunctions.For one malfunction, the investigation is confirmed for the alleged filter perforation.The remaining malfunction is inconclusive for the reported filter perforation.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
A review of the reported information indicates that model 2120f vena cava filter allegedly perforated.The information was received from various source.Both malfunctions were involved patients with no reported consequences.Of the two reported malfunctions, one female patient is 60 years and another patient age is 61 years; however, gender was not provided.Weight for both the patients were not provided.

• 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
• MDR Report Key: 11711393
• Report Number: 2020394-2021-80379
• Device Sequence Number: 11660414
• 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): 04/22/2021

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: GFQI0267,UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1