• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
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 was not provided; therefore, a lot history review was not performed. The sample was not returned. Medical records were not provided. Therefore, the investigation is inconclusive for the alleged perforation of the inferior vena cava (ivc), filter tilt, filter migration and retrieval difficulties. A definite root cause for the reported event could not be determined. The device was labeled for single use. (b)(4).

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model unknown vena cava filter allegedly experienced tilt, perforation, migration and difficult to remove. This information was received from one source. This malfunction involved one patient with no consequences. Age, weight, and gender were not provided for the patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG2 FILTER
Type of DeviceVENA 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 Key10311616
MDR Text Key199977819
Report Number2020394-2020-04974
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNKNOWN G2
Device LOT NumberUNKNOWN
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 Received06/30/2020
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

-
-