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

Model Number	5913190
Medical Device Problem Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for all the four reported malfunctions was provided, therefore lot history reviews were performed.The devices were not returned to the manufacturer for evaluation; however medical records were provided and reviewed for all the four malfunctions.The investigation for the four reported malfunctions are confirmed for tilt and perforation.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(corporate lot no - gfzf3889).
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced perforation and tilt.This information was received from various sources.The four malfunctions involved patients with no consequences.Of the four malfunctions, one male and three females ages were reported ranging from 44 to 77.The weight of one patient was (b)(6) kgs and the remaining patient weights are unknown.

• Brand Name: DENALI JUGULAR SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11219798
• Report Number: 2020394-2021-80095
• Device Sequence Number: 3556584
• Product Code: DTK
• UDI-Device Identifier: 00801741013836
• UDI-Public: (01)00801741013836
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 5913190
• Device Catalogue Number: DL900J
• Device Lot Number: GFYL3340, GFZK3565, GFYL1979
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/23/2021
• Patient Sequence Number: 1