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

Catalog Number DL950J

Device Problems Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the one reported event, the device was returned to bd and evaluated.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction event.A review of the event indicated that model dl950j vena cava filter was allegedly the leg of denali made a puncture in the introducer sheath while advancing through the sheath.This report was received from one source.Of the one event, did involved patient with no reported patient injury.The patients age, weight and gender were not provided.

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.This is the only complaint reported to date for this lot number and failure mode.One denali jugular filter system was returned for evaluation.Slight buckling was noted at the distal tip of the dilator; no other damage noted to the dilator.Perforation was noted to the sheath 54.9cm from the distal tip.Therefore, the investigation is confirmed for sheath puncture and buckled dilator tip.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction event.A review of the event indicated that model dl950j vena cava filter was allegedly the leg of denali made a puncture in the introducer sheath while advancing through the sheath.This report was received from one source.Of the one event, did involved patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: DENALI VENA CAVA FILTER - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8524917
• MDR Text Key: 142398924
• Report Number: 2020394-2019-00442
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: GFBV2357
• Date Manufacturer Received: 06/30/2019
• Patient Sequence Number: 1