MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER; VENA CAVA FILTER

Catalog Number UNK G2X

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was not provided, a lot history review was not performed.The sample was not returned to the manufacturer for evaluation.The investigation was inconclusive for reported difficult to remove, tilt and perforation.Based upon the available information, the definitive root cause is unknown.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the unknown model g2x filter allegedly reported difficult to remove, tilt and perforation.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient's age, sex and weight were unknown.

• Brand Name: G2X 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: 10306185
• MDR Text Key: 199843685
• Report Number: 2020394-2020-04810
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK G2X
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1