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

Catalog Number RF400J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A review of the reported information indicated that model rf400j vena cava filter allegedly experienced malposition of device, perforation, difficult to remove and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient weighs (b)(6) lbs.

• Brand Name: G2 EXPRESS 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: 12621504
• MDR Text Key: 276163563
• Report Number: 2020394-2021-80742
• 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): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2021

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: RF400J
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/13/2021
• Type of Device Usage: N
• Patient Sequence Number: 1