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

Catalog Number DL900J

Device Problems Positioning Failure (1158); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device has not been returned for evaluation; therefore, the investigation is inconclusive for failure to expand and failure to deploy as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction event.A review of the event indicated that model dl900j filter failed to expand and failed to deploy.It was reported that another filter was used to complete the procedure.This report was received from one source.The event involved a patient with no known impact to the patient.The male patient was (b)(6) years old and (b)(6) lbs.

• Brand Name: DENALI JUGULAR 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8279754
• MDR Text Key: 134181607
• Report Number: 2020394-2019-00040
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DL900J
• Device Lot Number: GFCV1527
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1