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

Catalog Number EC500F

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for two malfunctions; therefore, a lot history review was performed.The devices were not returned for either malfunction however medical records were received.The investigations are confirmed for positioning issues.Based upon the available information, the definitive root cause for this event is unknown.The devices are 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 positioning issues.The information was received from various source.Of the two malfunctions, both involved patients with no patient consequences.Of the two reported malfunctions one patient was male (b)(6) and other patient was female (b)(6).For both patient weight 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: 10306204
• MDR Text Key: 199846855
• Report Number: 2020394-2020-04811
• 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

• Date FDA Received: 07/21/2020
• 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: GFUA4094, GFUA3122
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1