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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for 3 out of 6 malfunctions, therefore a lot history reviews were performed.The devices were not returned for evaluation; however, medical records were provided and reviewed for all the 6 reported malfunctions.All the six reported malfunctions were confirmed for the alleged filter perforation.A definite root cause could not be determined based upon available information.The devices were labeled for single use.(corporate lot number: unknown).

Event Description

A review of the reported information indicates that model dl900j vena cava filter allegedly perforated.The information was received from various source.All the six reported malfunctions were involved with patients with no reported consequences.Four male patients ages were ranged from 61 to 75 years old and two female patient ages were ranged from 68 to 82 years old.Weight of two patients were ranged from 213 to 215 pounds; however,remaining patients weight were unknown.

• 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: 12221577
• MDR Text Key: 263353121
• Report Number: 2020394-2021-80673
• 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: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2021

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
• Device Operator: No Information
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFAX2513,GFXI2542,GFZD4318
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1