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

Catalog Number UNKNOWN FILTER

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

The lot number for the malfunctions was not provided; therefore, lot history reviews could not be performed.The devices have not been returned for evaluation.However, medical records were provided for each malfunction.One investigation confirmed for perforation and migration while the other investigation remains inconclusive for perforation and migration.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that an unknown vena cava filter model allegedly experienced perforation and migration.This information was received from one source.Each malfunction involved a patient with no known impact to the patient.One patient was a (b)(6) year-old female weighing (b)(6) kg.The other patient was a female weighing (b)(6) lb; age 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: 9969779
• MDR Text Key: 189221326
• Report Number: 2020394-2020-02888
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1