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

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.

• Brand Name: G2 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: 10311616
• MDR Text Key: 199977819
• Report Number: 2020394-2020-04974
• 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 G2
• 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