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

Model Number DL900F

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.However, medical record was received for evaluation.Therefore, the investigation is confirmed for the reported positioning issue.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

A review of the reported information indicates that model dl900f vena cava filter allegedly experienced positioning issue.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) years old female patient weighs (b)(6).

• Brand Name: DENALI FEMORAL 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: 12193027
• MDR Text Key: 262441422
• Report Number: 2020394-2021-80588
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2021

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: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFBQ3071
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/19/2021
• Type of Device Usage: N
• Patient Sequence Number: 1