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

Catalog Number UNKNOWN SNF

Device Problems Malposition of Device (2616); 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 inspection/evaluation; however, medical record and image were provided and reviewed.Therefore, the investigation is confirmed for the reported perforation, detachment and malposition of device.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

A review of the reported information indicates that model unknown snf vena cava filter allegedly experienced perforation, detachment and malposition of device.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) male patients weight was not provided.

• 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: 12623084
• MDR Text Key: 276138653
• Report Number: 2020394-2021-80747
• Device Sequence Number: 1
• Product Code: DTK
• 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

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN SNF
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1