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

Catalog Number EC500F

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model ec500f vena cava filter allegedly experienced obstruction.This information was received from various sources.Both malfunctions involved patients with no patient consequences.Age, gender and weight of both patients were not provided.

Manufacturer Narrative

H10: the lot number for both malfunctions were provided and a lot history review was performed.The devices for both malfunctions were not returned for evaluation, however, medical records were provided for one malfunction.The investigation for the malfunction that provided medical records is inconclusive.For the remaining malfunction, the investigation is inconclusive for obstruction as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model ec500f vena cava filter allegedly experienced obstruction.This information was received from various sources.Both malfunctions involved patients with no patient consequences.Age and weight of one male patient were not provided.Age, gender and weight of another patient 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
• MDR Report Key: 9602523
• MDR Text Key: 177943933
• Report Number: 2020394-2020-00592
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: GFUC2324, GFVL0176
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1