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

Catalog Number UNKNOWN FILTER

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

Of the 2 devices, lot numbers were not provided. The lot history reviews could not be performed. Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions. For both malfunctions, the investigation is confirmed for migration and patient device interaction problem; however, the investigation is unconfirmed malposition of device for one malfunction. Based upon the available information, the definitive root cause is unknown. The devices were labeled for single use.

Event Description

This report summarizes two malfunctions. A review of the reported information indicates that model unknown filter vena cava filter allegedly experienced migration and patient device interaction problem. The information was received from various sources. Of the two malfunctions, both involved patients with no patient consequences. Two female¿s ages were reported ranging from 40 to 48; however, the weights were not reported for both patients.

• Brand Name: NITINOL 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: 10311525
• MDR Text Key: 199980863
• Report Number: 2020394-2020-04968
• 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

• Type of Report: Initial
• Report Date: 07/22/2020

1 Device Was Involved in the Event

0 PatientS WERE 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: UNKNOWN FILTER
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage