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

Catalog Number DL950J

Device Problems Failure to Advance (2524); Positioning Problem (3009)

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.One filter was returned for evaluation.The device appeared clean with all limbs present and uncrossed.The investigation is inconclusive for the reported difficulties advancing the filter and positioning issue as no information surrounding filter deployment was provided.Per the provided event details, the filter was placed in an unexpected place because the filter was stuck into the sheath.Therefore, the difficulties advancing the filter likely resulted in the positioning issue.However, the definitive root cause for the deployment issues 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 dl950j filter experienced failure to advance and positioning issue.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 female patient¿s age and weight were not reported.

• Brand Name: DENALI JUGULAR SYSTEM
• 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: 8279930
• MDR Text Key: 134186922
• Report Number: 2020394-2019-00055
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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: DL950J
• Device Lot Number: GFCU2928
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1