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

Catalog Number	DL900F
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2025).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.H3 other text : device pending return.
Event or Problem Description
It was reported that during a vena cava filter placement procedure, the filter was allegedly detached in the introducer sheath and remained in the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiration date: 03/2025), g3.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.Device pending return.
Event or Problem Description
It was reported that during preparation of a vena cava filter placement procedure, the filter was allegedly detached in the introducer sheath and remained in the sheath.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
Our firm received an fda email correspondence on 06-aug-2024 from mdr data systems team, rebekah sykes, 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.Additionally, one denali femoral delivery system kit was returned (h3:d9).The touhy-borst adapter and the filter storage tube were received loaded to the pusher catheter.The filter was noted to be within the proximal end of the introducer sheath.An attempt was made to deploy the filter from the introducer sheath segment using an in-house mandrel and was successful.Filter limbs were present and uncrossed.Therefore, the investigation is confirmed for the reported device dislodged as the device was received with the filter within the proximal end of the introducer sheath.A definitive root cause for the reported device dislodged could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the reported event.D2: medical device type-dtk.D4: medical device expiration date- 03/31/2025.D4: udi-(b)(4).G4: k240257, k160866, k143208, k130366.
Event or Problem Description
It was reported that during preparation of a vena cava filter placement procedure, the filter allegedly detached in the introducer.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: 17866681
• Report Number: 2020394-2023-00783
• Device Sequence Number: 5954049
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)250331(10)GFGQ0173
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Expiration Date: 03/31/2025
• Device Catalogue Number: DL900F
• Device Lot Number: GFGQ0173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 08/06/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 01/31/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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