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

Model Number 2120F

Device Problems Malposition of Device (2616); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was not provided, a lot history review was not performed.The medical records were received and the sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported malfunction was confirmed for failure to expand, perforation and tilt.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model 2120f vena cava filter allegedly reported filter tilted, failed to expand and struts perforated.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a (b)(6) male and weighed (b)(6).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model 2120f vena cava filter allegedly reported filter tilted, failed to expand and struts perforated.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a 67-years old male and weighed 136 kg.

Manufacturer Narrative

H10: the previously reported mdr was submitted with an inaccurate fda rn number.The correct rn number should be 2020394 for this report.H10: the lot number for the device was not provided, a lot history review was not performed.The medical records were received and the sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported malfunction was confirmed for failure to expand, perforation and tilt.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.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.

• 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: 10289329
• MDR Text Key: 201730258
• Report Number: 2032230-2020-00003
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1