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

Catalog Number UNKNOWN FILTER

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation, however medical records were provided for review.Based on the medical records, the investigation is confirmed for perforation and inconclusive for filter tilt and retrieval difficulties.The definite root cause could not be determined based on the available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model unk filter vena cava filter allegedly experienced filter tilt, unable to retrieve and perforation.This report was received from one source.One patient was involved with no reported patient injury.One female patient age is (b)(6) years old and weight is not provided.

• Brand Name: NITINOL 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: 10305668
• MDR Text Key: 199842896
• Report Number: 2020394-2020-04796
• 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: UNKNOWN FILTER
• 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