MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER VENA CAVA FILTER

Catalog Number UNK G2X

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); 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 evaluation. Therefore, the investigation of the reported event is inconclusive for filter migration 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.

Event Description

This report summarizes one malfunction. A review of the reported information indicated that model unk vena cava filter allegedly experienced migration and perforation. This information was received from one source. This malfunction involved a patient with no consequences. Age, weight, and gender of the patient was not provided.

• Brand Name: G2X 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: 10308590
• MDR Text Key: 199887865
• Report Number: 2020394-2020-04903
• 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

• Type of Report: Initial
• Report Date: 07/22/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/22/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: UNK G2X
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage