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

Model Number 2320A

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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: 12621414
• MDR Text Key: 276448112
• Report Number: 2020394-2021-80738
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040924
• UDI-Public: (01)00801741040924
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 2320A
• Device Catalogue Number: 2320A
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/13/2021
• Type of Device Usage: N
• Patient Sequence Number: 1