MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SNF/SL; VENA CAVA FILTER

Catalog Number 2120F

Device Problems Malposition of Device (2616); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for evaluation.Therefore, the investigation is inconclusive for tilt, material deformation, and perforation.The root cause could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model unknown snf, vena cava filter, allegedly experienced tilt, material deformation, and perforation.This information was received from one source.This malfunction involved a patient with no consequences.The patient's age weight and gender were not provided.

Manufacturer Narrative

H10: the product catalog of the malfunction was updated to 2120f.The lot number was provided, therefore a lot history review was performed.The device was not returned for evaluation; however, medical records were provided and reviewed.The investigation is confirmed for deployment issue and positioning issue but is inconclusive for perforation, tilt, and material deformation.The definitive root cause could not be determined based upon available information.The device was labeled for single use.H10: g4, h6 (devices: 2906, 4001).H11: b5, g1, d4 (product catalog, corporate lot), h6 (results, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 2120f vena cava filter allegedly experienced perforation, tilt, material deformation, positioning issue, and deployment issue.This information was received from a single source.The malfunction involved a patient with no reported consequences.The patient was reported as a 38-year-old male whose weight was not provided.

• Brand Name: SNF/SL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9214458
• MDR Text Key: 163048661
• Report Number: 2020394-2019-04138
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2120F
• Device Lot Number: GFRF4639
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1