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

Catalog Number	DL900F
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that prior to a vena cava filter placement procedure, upon opening the package, the filter was allegedly predeployed partially into the sheath.There was no patient contact.
Additional Manufacturer Narrative
Our firm received an fda email correspondence on 06-aug-2024 from mdr data systems team, (b)(4), indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.**udi related data quality updates only** d4: medical device expiration date- although the lot number was requested, it was not provided by the complainant; therefore, the exp date is na.G4: k240257, k160866, k143208, k130366.
Event or Problem Description
It was reported that prior to a vena cava filter placement procedure, upon opening the package, the filter was allegedly predeployed partially into the sheath.There was no patient contact.

• Brand Name: DENALI FEMORAL SYSTEM
• Common Device Name: 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17972279
• Report Number: 2020394-2023-00906
• Device Sequence Number: 5033685
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown