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

Catalog Number EC500J

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the three reported malfunctions were provided, therefore, a lot history reviews were performed.The devices were not returned to the manufacturer for evaluation; however, medical records were provided and reviewed for all the three malfunctions.For two of the three malfunctions, the investigation is confirmed for the alleged perforation and filter tilt.The remaining malfunction is confirmed for perforation; however tilt is inconclusive.The definitive root cause could not be determined based upon available information.The devices are labeled for single use.

Event Description

This report summarizes three malfunctions.A review of the reported information indicates the model ec500j vena cava filter allegedly experienced filter tilt and perforation.The report was received from various source.All the three malfunctions were involved patients with no known impact to the patient.Of the three reported malfunctions, two male ages ranged from 73 to 80 years old; however, weight of one male patient was reported as (b)(6) pounds.The remaining female patient is (b)(6) years old and 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: 10756939
• MDR Text Key: 213865096
• Report Number: 2020394-2020-06282
• 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: 10/29/2020

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 Catalogue Number: EC500J
• Device Lot Number: GFXG3687,GFUL1925,GFUI2706
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1