MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) ECLIPSE FILTER; VENA CAVA FILTER

Catalog Number EC500J

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.The medical records were provided an reviewed.The investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for filter limb detachment.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ec500j vena cava filter allegedly experienced detachment and perforation.This information was received from one source.This malfunction involved a patient with no consequences.The patient was a (b)(6) year old male and his weight was not provided.

• Brand Name: ECLIPSE FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV)
• 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: 10298842
• MDR Text Key: 199650129
• Report Number: 2020394-2020-04670
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• 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: GFVA2441
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1