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

Model Number DL900J

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number was provided for two devices, a device history review was performed, the lot number was not provided for one malfunction and hence a device history review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation however, medical records were provided for review.A review of the medical records confirmed filter perforation and migration for all three malfunctions.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.

Event Description

This report summarizes three malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced perforation and migration.This information was received from various sources.Of the three malfunctions, three patients were involved with no patient consequences or impact.The three patients ranged from 54 through 92, one was male and two were female.The weight was not provided for any of the patients.

• Brand Name: DENALI 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: 10312814
• MDR Text Key: 200020293
• Report Number: 2020394-2020-04981
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFYA3092; GFYL3318; UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1