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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model ec500f vena cava filter allegedly experienced malposition of device, material deformation and difficult to remove.This report was received from one source.One patient was involved with no reported patient injury.The female patient age and weight is not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model ec500f vena cava filter allegedly experienced malposition of device, material deformation and difficult to remove.This report was received from one source.One patient was involved with no reported patient injury.The female patient age and weight is not provided.

Manufacturer Narrative

H10: the lot number for the device was provided, therefore a lot history review will be performed.The device was not returned, however, medical records were provided for review.The investigation is confirmed for filter tilt, material deformation and retrieval difficulties.A root cause has not been determined.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• MDR Report Key: 10291834
• MDR Text Key: 199462818
• Report Number: 2020394-2020-04625
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: GFYF3953
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1