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

Catalog Number RF310F

Device Problems Positioning Problem (3009); 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 malfunction and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Medical records were provided and reviewed.Therefore, the investigation was confirmed for positioning issues and perforation of ivc.A definite root cause for the reported event could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf310f vena cava filter allegedly experienced perforation and positioning issue.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 67 year old female is unknown.

• 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: 10312441
• MDR Text Key: 200004831
• Report Number: 2020394-2020-04985
• 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: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: GFRK3185
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1