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

Catalog Number RF048F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the devices were not provided, a lot history review was not performed.The samples were not returned to the manufacturer for evaluation; however, medical records were received and reviewed.For one malfunction, the investigation of the reported malfunctions was confirmed for material deformation and retrieval difficulties and inconclusive for filter tilt.For the other malfunction, the investigation is confirmed for tilt, material deformation and retrieval difficulties.Based upon the available information, the definitive root cause for these malfunctions were unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that the model rf048f vena cava filter allegedly reported filter difficult to remove, tilt and material deformation.This information was received from various sources.The two malfunctions involved patients with no known impact to the patient.The first patient was (b)(6) old male and the second patient was (b)(6) old male; however, the weights of both the patients were unknown.

• Brand Name: RECOVERY 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: 10308133
• MDR Text Key: 199874771
• Report Number: 2020394-2020-04887
• 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: 07/22/2020

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: RF048F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1