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

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the 2 devices, 2 lot numbers were provided.The lot history review was performed for one malfunction and lot history review will be performed for another malfunction.Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions.For one malfunction, the investigation is confirmed for migration and patient device interaction problem.For another malfunction, the company is still investigating the issue at this time.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicates that model ec500f vena cava filter allegedly experienced migration and patient device interaction problem.The information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.One male and one female¿s ages were reported ranging from 47 to 60; however, the weights were not reported for both patients.

Manufacturer Narrative

H10: of the 2 devices, 2 lot numbers were provided.The lot history review was performed for one malfunction and lot history review will be performed for another malfunction.Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions.For both the malfunctions, the investigation was confirmed for migration and patient device interaction problem.Based upon the available information, the definitive root cause is unknown.The devices were 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.

Event Description

This report summarizes two malfunctions.A review of the reported information indicates that model ec500f vena cava filter allegedly experienced migration and patient device interaction problem.The information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.One male and one female¿s ages were reported ranging from 47 to 60; however, the weights were not reported for both patients.

• Brand Name: ECLIPSE FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10306261
• MDR Text Key: 199843191
• Report Number: 2020394-2020-04812
• 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: 07/22/2020
• 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: GFWA4228, GFUH3015
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1