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

Catalog Number RF320J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the nine devices, five lot numbers were provided and lot history reviews were performed.All the nine devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For eight malfunctions, the investigations are confirmed for perforation of the inferior vena cava.For one malfunction, the investigation is confirmed for perforation of the inferior vena cava and unconfirmed for filter tilt.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.Corporate lot no: gfsd2826, gfrh5437, unknown.

Event Description

This report summarizes nine malfunctions.A review of the reported information indicated that model rf320j vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all nine patients with no consequences.Nine patients' ages were reported to be between 44-77 years and one patients weight was (b)(6) kgs, two patients were reported as male, and six patients were reported as female.All other patient details were not provided.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• 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: 11237783
• MDR Text Key: 228956740
• Report Number: 2020394-2021-80132
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF320J
• Device Lot Number: GFTK3545,GFRF4099,GFSD2034
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1