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

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); 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; however, medical records were received and reviewed.The investigation was confirmed for filter limb detachment and inconclusive for filter migration and perforation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model rf310f vena cava filter allegedly reported detachment, perforation and migration.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a (b)(6) years old female and weighed (b)(6) kg.

• 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: 10306186
• MDR Text Key: 199845036
• Report Number: 2020394-2020-04807
• 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

• 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
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1