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

Catalog Number RF320J

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

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 inspection/evaluation; however medical records were provided and reviewed.Therefore, the investigation of the reported malfunction is confirmed for filter migration and perforation.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model rf320j vena cava filter allegedly experienced perforation and migration.The information was received from a single source.One patient was involved with no reported patient impact or consequence.The male patient is (b)(6) years old.Weight of the patient 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: 10305845
• MDR Text Key: 199844037
• Report Number: 2020394-2020-04800
• 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: RF320J
• 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