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

Catalog Number EC500F

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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; however, medical records were provided for review.The investigation is confirmed for occlusion.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

A review of the reported information indicated that model ec500f vena cava filter allegedly experienced occlusion.This information was received from a single source.The malfunction involved a single patient with no reported consequences.The patient was reported as a (b)(6) year-old male who weighed (b)(6) kgs.

• Brand Name: ECLIPSE FILTER - FEMORAL
• 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: 12221040
• MDR Text Key: 263352009
• Report Number: 2020394-2021-80672
• 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): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: GFUD2504
• Date Manufacturer Received: 06/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1