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

Catalog Number EC500F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history reviewed.The sample was not returned for evaluation and medical records were provided.Material deformation and retrieval difficulties was confirmed for the device.The device was labeled for single use.A root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ec500f.Vena cava filter allegedly experienced difficult to remove and material deformation.This report was received from a single source.This event did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is male, however; the weight was not provided.

• Brand Name: ECLIPSE FILTER
• 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: 9216059
• MDR Text Key: 163131084
• Report Number: 2020394-2019-04190
• 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): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: GFVJ2197
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1