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); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for evaluation, however, medical records were provided for review.The investigation of the reported event is confirmed for filter migration and material deformation and it is inconclusive for filter limb detachment and perforation of the inferior vena cava.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(4001-patient device interaction problem).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf310f vena cava filter allegedly experienced detachment, perforation, material deformation and migration.This information was received from one source.This malfunction involved a patient with no consequences.The patient was a (b)(6) year old female and her weight was not provided.

• 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: 10305454
• MDR Text Key: 199839589
• Report Number: 2020394-2020-04782
• 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: RF310F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1