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

Catalog Number EC500F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for 12 of the 22 reported malfunctions was provided, therefore lot history reviews were performed.The samples were not returned to the manufacturer for inspection/evaluation however, medical records were provide for review for all the malfunctions as well as images were provided for two malfunctions.For twenty of the malfunctions, the investigation is confirmed for perforation.For the remaining two malfunctions, the investigation is confirmed for preformation, but is unconfirmed for tilt.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.(corporate lot: gfvf4248, gfub1685, gfxb3216, gfuf3055, gfuj2236, gfxa3809, gful1906, gfuc2337, unknown).

Event Description

This report summarizes 22 malfunctions.A review of the reported information indicated that model ec500f vena cava filter allegedly experienced perforation.This information was received from various sources.Of the 22 malfunction, 22 patients were involved with no patient consequences or impact.The patients' ages ranged from 35 to 83 years of age.Of the reported patients, 11 were male and 11 were female.Six patients' weights ranged from 210 - 480 pounds.The remaining patients' weights were 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: 10303368
• MDR Text Key: 199728245
• Report Number: 2020394-2020-04758
• 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: 07/21/2020

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: EC500F
• Device Lot Number: GFUC2336, GFUB1656, GFWD0778
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1