MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number EC500F

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

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

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation is confirmed for filter migration; however, the investigation is inconclusive for perforation of inferior vena cava.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 ec500f vena cava filter allegedly experienced migration and patient device interaction problem.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: ECLIPSE FILTER SYSTEM - FEMORAL
• 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: 12198061
• MDR Text Key: 262504311
• Report Number: 2020394-2021-80621
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EC500F
• Device Lot Number: GFVK0243
• Date Manufacturer Received: 06/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1