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

Model Number DL900J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the ten devices, nine lot numbers were provided and lot history reviews were performed.All the ten devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For six malfunctions, the investigations are confirmed for filter perforation of the inferior vena cava.For one malfunction, the investigation is inconclusive for perforation of the inferior vena cava.For the remaining three malfunctions, the investigations are confirmed for filter perforation of the inferior vena cava and unconfirmed for tilt.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.(corporate lot no: unknown, gfzj0451, gfzc3726, gfyf3862, gfza0738, gfbr1938, gfbq0958).

Event Description

This report summarizes ten malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all ten patients with no consequences.Of the ten patients, nine patients' ages were reported to be between 34-72 years and three patients¿ weight were reported to be between 75-124 kgs, four patients were reported as female, and six patients were reported as male.All other patient details were not provided.

• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11227932
• MDR Text Key: 228684984
• Report Number: 2020394-2021-80130
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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: GFYJ3690,GFYI2670,GFYL3402
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1