MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The lot number for the three malfunctions were not provided and hence a lot history review was not performed. For the three malfunctions the sample was not returned to the manufacturer for inspection/evaluation. For one malfunction medical records were provided and reviewed and the investigation is confirmed for filter migration, filter tilt and retrieval difficulties. For the other two malfunctions medical records were provided and the investigation identified filter migration, filter tilt and retrieval difficulties. A definite root cause for the reported event could not be determined. The device was labeled for single use.

Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model rf310f vena cava filter allegedly experienced difficult to remove, tilt and migration. These reports were received from various sources. All three events involved a patient with no reported patient consequences. Of the three reported patient, three patients ranged from 30 ¿ 68 years of age, one patient weight was 108 kgs and two were male and one was female; however, other patients weight was not provided.

• Brand Name: G2 FILTER SYSTEM - 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: 10309561
• MDR Text Key: 199915244
• Report Number: 2020394-2020-04932
• 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: RF310F
• 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: Initial