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

Model Number	2320A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided and reviewed.The investigation is confirmed for perforation of the inferior vena cava and detachment.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
A review of the reported information indicated that model 2320a vena cava filter allegedly experienced perforation and detachment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) female patient weighs (b)(6).

• 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: 12621414
• Report Number: 2020394-2021-80738
• Device Sequence Number: 11064158
• Product Code: DTK
• UDI-Device Identifier: 00801741040924
• UDI-Public: (01)00801741040924
• 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): 10/13/2021

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: 2320A
• Device Catalogue Number: 2320A
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1