MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 EXPRESS FILTER VENA CAVA FILTER

Catalog Number RF400J

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

The lot number was provided for the reported malfunction; therefore, a lot history review was performed. The sample was not returned to the manufacturer for evaluation. However, medical records were provided and reviewed. Therefore, the investigation is confirmed for perforation of the ivc filter. However the investigation is inconclusive for the filter migration. 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 indicates that model rf400j vena cava filter allegedly experienced migration of device component, patient device interaction problem. The information was received from one source. One patient was involved with no reported patient injury. The female patient age and weight were not provided.

• Brand Name: G2 EXPRESS 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: 10309585
• MDR Text Key: 199917284
• Report Number: 2020394-2020-04934
• 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: RF400J
• Device LOT Number: GFSK1775
• 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